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Philippine Obstetrical and


Gynecological Society (POGS), Foundation, Inc.

CLINICAL PRACTICE GUIDELINES


on
ABORTION

November 2010

Task Force on Clinical Practice Guidelines on Abortion


Philippine Obstetrical and
Gynecological Society (POGS),
Foundation, Inc.

CLINICAL PRACTICE GUIDELINES


on
ABORTION

November 2010

Task Force on Clinical Practice Guidelines on Abortion


FOREWORD!

REGTA L. PICHAY, MD
President
Philippine Obstetrical and Gynecological Society (Foundation), Inc. (POGS), 2010

REGTA L. PICHAY, MD
INTRODUCTION!

EFREN J. DOMINGO, MD, PhD


Editor in Chief, Clinical Practice Guidelines, 2010

The Clinical Practice Guidelines on Abortion is the First Edition of this


Publication, 2010. The Philippine Obstetrical and Gynecological Society,
(Foundation), Inc. (POGS), through the Committee on Clinical Practice
Guidelines initiated and led to completion the publication of this manual in
plenary consultation with the Residency Accredited Training Hospitals’ Chairs
and Training Officers, The Regional Board of Directors, The Board of
Trustees, The Task Force on Abortion and the Committee on Clinical Practice
Guidelines (CPG).

This publication represents the collective effort of the POGS in


updating the clinical practice of Obstetrics and Gynecology, specifically on
Abortion, and making it responsive to the most current and acceptable
standard in this procedure. A greater part of the inputs incorporated in this
edition are the contributions originating from the day-to-day academic
interactions from the faculty of the different Residency-Accredited Hospitals in
Obstetrics and Gynecology in the country.

This Clinical Practice Guideline on Abortion is envisioned to become


the handy companion of the Obstetrician-Gynecologist in his/her day-to-day
rendition of quality care and decision making in managing the Obstetric
patient. This is also envisioned to provide the academic institutions in the
country and in Southeast Asia updated information on diagnosis and
management of Abortion as being practiced in the Philippines.

Profound gratitude is extended to all the members of the POGS, the


Chairs and Training Officers of the Residency-Training Accredited Institutions,
the Regional Directors, The Task Force Reviewers/Contributors, The CPG
Committee members, and the 2010 POGS Board of Trustees.

EFREN J. DOMINGO, MD, PhD


BOARD OF TRUSTEES 2010

OFFICERS

Regta L. Pichay, MD
President

Sylvia delas Alas Carnero, MD


Vice President

Ditas Cristina D. Decena, MD


Secretary

Jericho Thaddeus P. Luna, MD


Treasurer

Gil S. Gonzales, MD
Public Relations Officer

BOARD OF TRUSTEES
Efren J. Domingo, MD, PhD
Virgilio B. Castro, MD
Blanca C. de Guia-Fuerte, MD
Raul M. Quillamor, MD
Rey H. delos Reyes, MD
Ma. Cynthia Fernandez-Tan, MD
COMMITTEE ON CLINICAL PRACTICE GUIDELINES

Efren J. Domingo, MD, PhD


Editor in Chief

MEMBERS
Ann Marie C. Trinidad, MD Ma. Victoria V. Torres, MD
Lisa T. Prodigalidad-Jabson, MD Christine D. Dizon, MD
Rommel Z. Duenas, MD

MANAGING EDITOR
Ana Victoria V. Dy Echo, MD

TECHNICAL STAFF ASSISTANTS


Ms. Emiliana C. Enriquez Ms. Jhasmin G. De Guzman

TASK FORCE ON ABORTION

Rommel Z. Duenas, MD
Chair

Members
Sybil Lizanne R. Bravo, MD
Maria Lourdes B. Coloma, MD
Lorina Q. Esteban, MD
Aida V. San Jose, MD
Florentina A. Villanueva, MD
Ma. Corazon N. Zaida-Gamilla, MD

TASK FORCE REVIEWERS AND PLENARY REVIEWERS

Rainerio S. Abad, MD Ma. Flores Adiong, MD Almira Amin-Ong, MD


Imelda O. Andres, MD Ruth Jinky Aposaga, MD Prudence V. Aquino, MD
Nurlinda Arumpac, MD Ricardo Braganza, MD Maria Nelvez Candilario, MD
Grace D. Caras, MD Abigail Elsie D. Castro, MD Ma. Theresa Cedullo, MD
Ma. Cherrie Climaco, MD Antonio Cortez, MD Lara David-Bustamante, MD
Macrina A. De Guzman, MD Grace D. delos Angeles, MD Rodante P. Galiza, MD
Gil S. Gonzales, MD Maribel Hidalgo-Co, MD Jennifer Jose, MD
May N. Hipolito, MD Rosemarie R. Hudencial, MD Humildada Asumpta Igana, MD
Margarette Lavalle, MD Lourdes Ledesma, MD Jericho Thaddeus P. Luna, MD
Ma. Teresa A. Luna, MD Ma. Cecilia Maclang, MD Marilou Mangubat, MD
Corazon B. Mata, MD Jocelyn Z. Mariano, MD Rudie Frederick B. Mendiola, MD
Marites Mendoza, MD Suzette Miclat, MD Manuel S. Ocampo, MD
Cristia S. Padolina, MD Mary Christine F. Palma, MD Belen Pantangco-Rajagukguk, MD
Gladys Pelicano, MD Regta L. Pichay, MD Sarah Pingol, MD
Kenet Prado, MD Ma. Carmen H. Quevedo, MD Rico E. Reyes, MD
Ricalynn Rivera, MD Bella G. Rodriguez, MD Pura Rodriguez-Caisip, MD
Alice Salvador, MD Jean Marie Salvador, MD Esmarliza Tacud-Luzon, MD
Patricia L. Tan, MD Ma. Theresa B. Tenorio, MD Jean Anne B. Toral, M
Florentina A. Villanueva, MD Julieta Villanueva, MD Faith Villaruiz, MD
Marilou Viray, MD Regina P. Vitriolo, MD Amaryllis Digna A. Yazon, MD

Regional Directors
Betha Fe M. Castillo, MD (Region 1) Noel C. de Leon, MD (Region 2)
Concepcion P. Argonza, MD (Region 3) Ernesto S. Naval, MD (Region 4)
Diosdado V. Mariano, MD (Region 4A NCR) Cecilia Valdes-Neptuno, MD (Region 5)
Evelyn R. Lacson, MD (Region 6) Belinda N. Pañares, MD (Region 7)
Fe G. Merin, MD (Region 8) Cynthia A. Dionio, MD (Region 9)
Jana Joy R. Tusalem, MD (Region 10) Ameila A. Vega, MD (Region 11)

DISCLAIMER, RELEASE AND WAIVER OF RESPONSIBILITY

• This is the Clinical Practice Guidelines (CPG) on Abortion, First Edition,


November 2010.
• This is the publication of the Philippine Obstetrical and Gynecological Society,
(Foundation), Inc. (POGS).
• This is the ownership of the POGS, its officers, and its entire membership.
• The obstetrician gynecologist, the general practitioner, the patient, the student, the
allied medical practitioner, or for that matter, any capacity of the person or
individual who may read, quote, cite, refer to, or acknowledge, any, or part, or the
entirety of any topic, subject matter, diagnostic condition or idea/s willfully
release and waive all the liabilities and responsibilities of the POGS, its officers
and general membership, as well as the Committee on the Clinical Practice
Guidelines and its Editorial Staff in any or all clinical or other disputes,
disagreements, conference audits/controversies, case discussions/critiquing.
• The reader is encouraged to deal with each clinical case as a distinct and unique
clinical condition, which will never fit into an exact location if reference is made
into any or all part/s of this CPG.
• The intention and objective of this CPG is to serve as a guide, to clarify, to make
clear the distinction. It is not the intention or objective of this CPG to serve as the
exact and precise answer, solution and treatment for clinical conditions and
situations. It is always encouraged to refer to the individual clinical case as the
one and only answer to the case in question, not this CPG.
• It is hoped that with the CPG at hand, the clinician will find a handy guide that
leads to the a clue, to a valuable pathway that leads to the discovery of clinical
tests leading to clinical treatments and eventually recovery.
• In behalf of the POGS, its Board of Trustees, the Committee on The Clinical
Practice Guidelines, 2010, this CPG is meant to make each one of us a perfect
image of Christ, the Healer.
CPG ON ABORTION
TOPICS / CONTENTS / AUTHOR/S!

I. Spontaneous Abortion: Definition, Clinical Manifestations and Diagnosis


Dr. Aida V. San Jose, Dr. Florentina A. Villanueva
II. Spontaneous Abortion: Management
Dr. Ma. Corazon N. Zaida-Gamilla, Dr. Maria Lourdes B. Coloma
III. Recurrent Abortion
Dr. Aida V. San Jose, Dr. Florentina A. Villanueva
IV. Unsafe Abortion
Dr. Sybil Lizanne R. Bravo and Dr. Lorina Q. Esteban
V. Levels of Evidence and Grades of Recommendations
SPONTANEOUS ABORTION
Definition, Clinical Manifestations and Diagnosis
Aida V. San Jose, MD and Florentina A. Villanueva, MD

Definition

1. Abortion is any loss of a fetus that is less than 20 weeks age of gestation
(AOG), or that which weighs less than 500 g.

Supporting Statement

This is based on definitions used by the National Center for Health


Statistics, the Centers for Disease Control and Prevention, and the World
Health Organization.

2. Abortion is a pregnancy loss under 24 weeks. (Level III, Grade C)

Supporting Statement

Since institutions have reported survival of infants at 24 weeks, and no


definition to cover 21-23 weeks AOG, a slight modification in the definition is
recommended.2

3. The medical term which should be used in explaining this condition to


patients should be “Miscarriage”.

Supporting Statements

The term “abortion” may give the woman a negative self-perception


which may worsen her sense of failure, shame, guilt and insecurity in
spontaneous abortions. In 2005, the European Society for Human
Reproduction (ESHRE) Special Interest Group for Early Pregnancy (SIGEP)
published a revised nomenclature for use in early pregnancy loss in order to
improve clarity and consistency of terms.3 The terms in Table 1 are
recommended.

Table 1. Terminologies
Previous Term Recommended Term
Spontaneous abortion Miscarriage
Threatened abortion Threatened miscarriage
Inevitable abortion Inevitable miscarriage
Incomplete abortion Incomplete miscarriage
Complete abortion Complete miscarriage
Missed abortion / anembryonic pregnancy / Missed miscarriage / early fetal demise /
blighted ovum (these reflect different stages in delayed miscarriage / silent miscarriage
the same process)
Septic abortion Miscarriage with infection (sepsis)
Recurrent abortion Recurrent miscarriage
Causes of Abortion

I. Embryonic abnormalities
Chromosomal abnormalities (e.g. Trisomy)

II. Maternal factors


Chronic maternal health factors:
Maternal insulin-dependent diabetes mellitus (IDDM)
Severe hypertension
Renal disease
Systemic lupus erythematosus (SLE)
Hyperthyroidism
Acute maternal health factors:
Infections (e.g., rubella, cytomegalovirus [CMV], mycoplasmal, ureaplasmal,
listerial, toxoplasmal infections)
Trauma
Severe emotional shock

III. Other factors that may contribute to miscarriage


Exogenous factors:
Alcohol
Tobacco
Cocaine and other illicit drugs
Anatomic factors:
Congenital anatomic lesions include müllerian duct anomalies (e.g. septate
uterus, diethylstilbestrol [DES]-related anomalies) and anomalies of the
uterine artery
Acquired lesions include intrauterine adhesions (i.e. synechiae), leiomyoma,
and endometriosis
Endocrine factors:
Luteal phase insufficiency (i.e. abnormal corpus luteum function with
insufficient progesterone production), hypothyroidism, hypoprolactinemia,
poor diabetic control, and polycystic ovarian syndrome
Infectious factors:
Bacterial, viral, parasitic, fungal, and zoonotic
Immunologic factors:
Antiphospholipid antibody syndrome
Miscellaneous factors:
Environment, drugs, placental abnormalities, medical illnesses, and male-
related causes

Clinical Manifestations

Spontaneous abortion can be classified clinically by the following:


threatened, inevitable, incomplete, missed abortion, septic abortion and recurrent
miscarriage - also termed recurrent pregnancy loss.

1. Threatened Miscarriage: Vital signs should be within normal limits unless


infection is present or hemorrhage has caused hypovolemia. Pregnant woman
presents with bloody vaginal discharge with or without hypogastric pain, with
or without low back pain. The abdomen usually is soft and nontender. Pelvic
examination reveals a closed internal cervical os. The bimanual examination is
unremarkable.

Supporting Statements

This may develop in 20-25% of women during early gestation and may
persist for days or weeks. According to Tongson, et. al., approximately half of
these pregnancies will abort, although the risk is substantially lower if fetal
cardiac activity is visualized. In 2006, Eddleman stated that the bleeding
during the current pregnancy was the most predictive risk factor for pregnancy
loss. Authors mentioned that even if abortion does not follow early bleeding,
these fetuses are at increased risk for preterm delivery, low birthweight, and
perinatal death.1

2. Inevitable Miscarriage: The sudden discharge of fluid is accompanied or


followed by vaginal bleeding. This vaginal bleeding is often associated with
abdominal pain and cramping.

Supporting Statements

Gross rupture of the membranes, evidenced by leaking amnionic fluid


in the presence of cervical dilatation, signals almost certain abortion. If,
however, the gush of fluid is accompanied or followed by bleeding, pain, or
fever, abortion should be considered inevitable, and the uterus emptied.
Vaginal bleeding is accompanied by dilatation of the cervical canal. Bleeding
is usually more severe than with threatened miscarriage.1

3. Incomplete Miscarriage: On pelvic examination, products of conception may


be partially present in the uterus, may protrude from the external os, or may be
present in the vagina. The cervical os may appear dilated and effaced, or it
may be closed. Vaginal bleeding may be intense and accompanied by
abdominal pain. On bimanual examination may reveal an enlarged and soft
uterus.

Summary of Evidence

Before 10 weeks, the fetus and placenta are commonly expelled


together, but later they are delivered separately. Bleeding ensues when the
placenta, in whole or in part, detaches from the uterus. Hemorrhage from
incomplete abortion of a more advanced pregnancy is occasionally severe but
rarely fatal.1

4. Complete Miscarriage: Bleeding and pain have subsided. On pelvic


examination, the cervix should be closed, and the uterus should be contracted.

Supporting Statements

Patients may present with a history of bleeding, abdominal pain, and


tissue passage. By the time the miscarriage is complete, bleeding and pain
usually have subsided. Diagnosis may be confirmed by observation of the
aborted fetus with the complete placenta, although caution is recommended in
making this diagnosis without ultrasound because it can be difficult to
determine if the miscarriage is complete.1

5. Missed Miscarriage – early pregnancy failure: Vital signs usually are


within normal limits. Abdominal examination may or may not reveal a
palpable uterus. If palpable, the uterus usually is small for the presumed
gestational age. Fetal heart tones are inaudible or unseen on sonogram. The
cervical os is closed upon pelvic examination. The uterus may feel soft and
enlarged.

Supporting Statements:

Because spontaneous miscarriages are almost always preceded by


embryo or fetal death, most were correctly referred to as "missed." In the
typical instance, early pregnancy appears to be normal, with amenorrhea,
nausea and vomiting, breast changes, and uterine growth. After embryonic
death, there may or may not be vaginal bleeding or other symptoms of
threatened abortion. Thus, the dead products of conception were retained for
days, weeks, or even months in the uterus with a closed cervical os.1

Diagnosis

1. Clinical history: Patients with spontaneous miscarriage usually present


with vaginal bleeding, abdominal pain, or both.

Supporting Statements

Vaginal bleeding may vary from slight spotting to a severe life-


threatening hemorrhage. The patient's history should include the number of
pads used. Heavy bleeding in the first trimester, particularly when associated
with abdominal pain, is associated with higher risk of miscarriage. Presence
of blood clots or tissue may be an important sign indicating progression of
spontaneous miscarriage. Abdominal pain is usually located in the suprapubic
area or in one or both lower quadrants. Pain may radiate to the lower back,
buttocks, genitalia, and perineum.1

2. Physical examination should focus on detemining the source of bleeding.

Supporting Statements

The following should be included in the determining the source of


bleeding, blood from cervical os, intensity of bleeding, presence of clots or
tissue fragments, cervical motion tenderness, status of internal cervical os:
open indicates inevitable or possibly incomplete miscarriage; closed indicates
threatened miscarriage, uterine size and tenderness, as well as adnexal
tenderness or masses.1
3. Ultrasound: With the introduction of transvaginal ultrasound (TVS),
longitudinal assessment of early pregnancy development can be made in
terms of viability and growth.3

Supporting Statements

Ultrasound plays a major role in: maternal reassurance, where fetal


cardiac activity is seen pivotal in the assessment of early pregnancy
complications, such as vaginal bleeding. However, there are limits to
ultrasound resolution of normal early pregnancy development.
The most common TVS finding prior to 35 days was a pregnancy of
unknown location (PUL) or an intrauterine pregnancy of uncertain viability
(IPUVI), from 35 to 41 days an early intrauterine pregnancy of uncertain
viability and from 42 days a viable intrauterine pregnancy.
Miscarriage could only be diagnosed on initial TVS after 35 days.4 A
diagnosis of “anembryonic pregnancy” or “early embryonic demise” or
“embryo loss” should not be made if the visible crown–rump length (CRL) is
less than 6 mm, as only 65% of normal embryos will display cardiac activity.2
Repeat TVS examination after at least a week, showing identical
features and/or the presence of fetal bradycardia, is strongly suggestive of
impending miscarriage.2 When the fetus has clearly developed and the fetal
heart is absent, the term ‘missed abortion’ should be replaced by “delayed
miscarriage”.
The following findings on TVS which are suggestive of possible
pregnancy failure, or pregnancy of questionable viability:5
• Failure to visualize an intrauterine pregnancy by TVS when the !
subunit human chorionic gonadotropin (!-hCG) level is between
1000-2000 mIU/mL – also known as discriminatory level of !-hCG
• Failure to detect a yolk sac when the mean sac diameter (MSD) is ! 8
mm
• Failure to detect cardiac activity when the MSD is ! 16 mm
• If the MSD fails to increase in size by at least 0.6 mm/day
• Absent cardiac activity if the CRL ! 5 mm
• When the difference between CRL and MSD is < 5mm, this is
oligohydramnios. The incidence of spontaneous abortion in these
cases is 80-94%, even if there is cardiac activity.
• Yolk sac > 6 mm may be predictive of pregnancy failure, or a fetus of
a mother with insulin-dependent diabetes
• Yolk sacs which are abnormally shaped, calcified, echogenic or double
(with vitelline cyst)
• Visible amnion when the CRL < 7 mm
• Visible amnion > 6 mm without an embryo
• Fetal bradycardia defined as fetal heart rate (FHR) < 100 beats per
minute (bpm) before 6.2 weeks AOG, and < 120 bpm between 6.3-7
weeks should be investigated because this might mean pregnancy
failure or chromosomal and structural anomalies (e.g. trisomy 18 and
triploidy)
• Fetal tachycardia at 10-14 weeks is associated with trisomy 21, trisomy
13, and Turner syndrome
4. Serum !-hCG: For PUL or IPUVI, serial serum !-hCG assay is
important.4 (Level III, Grade B)

Supporting Statements

!-hCG is detectable in the serum of approximately 5% of patients 8


days after conception and in more than 98% of patients by day 11.4
At 4 weeks AOG (18-22 days postconception), the dimer and !-hCG
doubling times are approximately 2.2 days (standard deviation [SD] ± 0.8
days) and fall to 3.5 days (SD ± 1.2 days) by 9 weeks AOG.
Levels peak at 10-12 weeks AOG and then begin to decline rapidly
until another, more gradual rise begins at 22 weeks AOG, which continues
until term.4
The initial rate of rise, measured by serial quantitative !-hCG testing,
is important in the monitoring of early complicated pregnancies that have yet
to be documented as viable and/or intrauterine.4
Failure to achieve the projected rate of rise may suggest an ectopic
pregnancy or spontaneous abortion. Serial serum !-hCG assay is particularly
useful in the diagnosis of asymptomatic ectopic pregnancy.2

5. Serum progesterone assay can be a useful adjunct when ultrasound


suggests pregnancy of unknown location. (Level III, Grade B)

Supporting Statement

TVS, serial serum !-hCG levels, and progesterone may all be required
in order to establish a definite diagnosis.2

References

1. Cuningham G, et al (Eds). “Abortion” In: Williams Obstetrics. McGraw-Hill Companies, Inc.


2010.
2. Royal College of Obstetricians and Gynaecologists (RCOG). The management of early
pregnancy loss. Royal College of Obstetricians and Gynaecologists (RCOG) Guideline No.
25. 2006;18.
3. European Society of Human Reproduction and Embryology (ESHRE) Special Interest Group
for Early Pregnancy (SIGEP). Updated and revised nomenclature for description of early
pregnancy events. Human Reproduction 2005;20(11):3008-3011.
4. Bottomley C, Van Belle V, Mukri F, Kirk E, Van Huffel S, Timmerman D, Bourne T. The
optimal timing of an ultrasound scan to assess the location and viability of an early pregnancy.
Human Reproduction 2009;24(8):1811-1817.
5. Callen P (Ed). “Ultrasound evaluation during the first trimester” In: Ultrasonography in
Obstetrics and Gynecology, 5th edition. 2008.
6. Gaufberg SV. Early pregnancy loss. Contributor Information and Disclosures. Updated: April
16, 2010.
7. Shields AD. Pregnancy diagnosis. Contributor Information and Disclosures. Updated: April
20, 2009.
8. Stubblefield PG, Grimes DA. Septic abortion. New Engl J Med 1994;331(5): 310-314.
9. Broklehurst TJ, et al. Management of miscarriage: expectant, medical, or surgical? Results of
randomised controlled trial (miscarriage treatment (MIST) trial). Br Med J 2006;332:1235-
1240.
10. Finkielman JD, De Feo FD, Heller PG, Afessa B. The clinical course of patients with septic
abortion admitted to an intensive care unit. Intensive Care Med 2006;30(6).
11. Davis VJ. Induced abortion guidelines. SOGC Clinical Practice Guidelines 2006;184.
12. Chan FY, Ghosh A, Tang M, Ng J. Ultrasound in prenatal diagnosis: use and pitfalls. J Hong
Kong Med Assoc 1991;43(2).
SPONTANEOUS ABORTION
Management
Ma. Corazon N. Zaida-Gamilla and Maria Lourdes B. Coloma

Threatened Abortion

1. There is no evidence to support bed rest, progestogens, and vitamin


supplementation as advantageous in the prevention of miscarriage. (Level
I, Grade A)

Supporting Statements

The review of Aleman, et. al. netted only 2 studies including 84


women. These showed no statistically significant difference in the risk of
miscarriage in the bed rest group versus the no bed rest group (placebo or
other treatment) (relative risk [RR] 1.54, 95% CI 0.92-2.58). Neither bed rest
in hospital nor bed rest at home showed a significant difference in the
prevention of miscarriage. There was a higher risk of miscarriage in those
women in the bed rest group than in those in the human chorionic
gonadotropin (hCG) therapy group with no bed rest (RR 2.50, 95% CI 1.22-
5.11). However, the number of participants is too small to provide evidence of
high quality towards a policy of bed rest in order to prevent miscarriage in
women with confirmed fetal viability and vaginal bleeding in first half of
pregnancy.1
Similarly, 17 randomized and quasi-randomized trials comparing one
or more vitamins with either placebo, other vitamins, no vitamins or other
interventions, prior to conception, periconceptionally or in early pregnancy
(less than 20 weeks gestation) showed that taking vitamin supplements, alone
or in combination with other vitamins, prior to pregnancy or in early
pregnancy, does not prevent women experiencing miscarriage or stillbirth.2
The meta-analysis by Haas, et. al., of 15 trials including 2114 women
regardless of gravidity and number of previous miscarriages, showed no
statistically significant difference in the risk of miscarriage between
progestogen and placebo or no treatment groups (Peto odds ratio (Peto OR)
0.98; 95% CI 0.78-1.24) and no statistically significant difference in the
incidence of adverse effect in either mother or baby.3

2. Progestogen may be beneficial in women who have had 3 or more prior


miscarriages. (Level I, Grade A)

Supporting Statements

In the subgroup analysis by Haas, et. al. of 3 trials involving women


who had recurrent miscarriages (3 or more consecutive miscarriages),
progestogen treatment showed a statistically significant decrease in
miscarriage rate compared to placebo or no treatment. No statistically
significant differences were found between the route of administration of
progestogen (oral, intramuscular, vaginal) versus placebo or no treatment. So
while there is insufficient evidence to support routine use of progestogen to
prevent miscarriage in early to mid-pregnancy, there seems to be evidence of
benefit in women with several previous miscarriages.3

Incomplete Abortion

1. Surgical evacuation is acceptable as standard and traditional practice.


(Level I, Grade A)

2. Expectant management is also an acceptable alternative but it carries


higher risk of incomplete miscarriage and bleeding, and subsequent need
for surgical emptying of the uterus. (Level I, Grade A)

Supporting Statements

Multiple randomized controlled trials (RCTs) and cohort studies


reviewed by Butler, et. al. have demonstrated that more than 80% of women
with a first trimester spontaneous abortion have complete natural passage of
tissue within 2 to 6 weeks with no higher complication rate than that from
surgical intervention.4 This is the basis for so-called expectant management.
Obviously, surgical evacuation is the management of choice in women
experiencing spontaneous abortion with unstable vital signs, uncontrolled
bleeding, or evidence of infection.
The miscarriage treatment trial (MIST) saw that the incidence of
gynecological infection after surgical, expectant, and medical management of
first trimester miscarriage is low (2-3%) and no evidence exists of a difference
by the method of management.5 However, significantly more unplanned
admissions and unplanned surgical curettage occurred after expectant
management and medical management than after surgical management.
Five trials with 689 total participants were included in the review of
Nanda, et. al.6 Expectant management led to a higher risk of incomplete
miscarriage, need for surgical emptying of the uterus, and bleeding. None of
these were serious. In contrast, surgical evacuation was associated with a
significantly higher risk of infection. As neither approach was advantageous,
the investigators propose that the woman’s choice be considered in decision-
making.
Analysis of cases with incomplete miscarriage by Sortiades, et. al
showed that complete evacuation of the uterus was significantly more
common with surgical than medical management (risk difference 32.8%,
number needed to treat [NNT] 3, success rate of medical management 62%)
and with medical than expectant management (risk difference 49.7%, NNT 2).
Success rate with expectant management was spuriously low (39%) in the
latter comparison.
Neilson, et. al. reviewed 15 RCTs comparing medical treatment with
expectant care or surgery. Studies addressed a number of comparisons and
data are therefore limited. Three trials compared misoprostol treatment (all
vaginally administered) with expectant care. There was no significant
difference in complete miscarriage (average RR 1.23, 95% CI 0.72-2.10; two
studies, 150 women), or in the need for surgical evacuation (average RR 0.62,
95% CI 0.17-2.26; two studies, 308 women). There were few data on 'deaths
or serious complications’.
Nine studies involving 1766 women addressed the comparison of
misoprostol (four oral, four vaginal, one vaginal + oral) with surgical
evacuation. There was no statistically significant difference in complete
miscarriage (average RR 0.96, 95% CI 0.92-1.00, eight studies, and 1377
women) with success rate high for both methods. Overall, there were fewer
surgical evacuations with misoprostol (average RR 0.07, 95% CI 0.03-0.18;
eight studies, 1538 women) but more unplanned procedures (average RR 6.32,
95% CI 2.90-13.77; six studies, 1158 women). The evidence thus suggests that
medical treatment, with misoprostol, and expectant care are both acceptable
alternatives to routine surgical evacuation given the availability of health
service resources to support all three approaches. Women experiencing
miscarriage at less than 13 weeks should be offered an informed choice.

3. Manual vacuum aspiration (MVA) and sharp curettage have comparable


advantages. (Level I, Grade A)

Supporting Statements

Forna, et. al. reviewed trials comparing the safety and effectiveness of
those procedures.7 MVA was associated with statistically significantly
decreased blood loss (-17 ml weighted mean difference [WMD], 95% CI -24
to -10 ml), less pain (RR 0.74, 95% CI 0.61-0.90), and shorter duration of
procedure (-1.2 minutes WMD, 95% CI -1.5 to -0.87 minutes), than sharp
curettage, in the single study that evaluated these outcomes. Complications
such as uterine perforation and other morbidity were rare and the sample sizes
of the trials were not large enough to evaluate small or moderate differences.
Similarly, the 11 trials studied by Kulier, et. al. do not indicate overall
benefits of one over the other method.11 MVA can be used for early first
trimester surgical abortion, but maybe more difficult when used after the 9th
week of gestation. A retrospective study by Milingos, et. al. of 246 patients
who were scheduled to undergo MVA for first trimester early fetal demise and
first and mid-trimester incomplete miscarriage demonstrated 94.7% (232/245)
efficacy of the procedure. Incomplete uterine evacuation was seen in 5.3%
(13/245) patients.12

4. Antibiotics are to be used when indicated. (Level I, Grade A)

Supporting Statements

Antibiotics are indicated management where there are signs of


infection in a case of incomplete abortion, especially when unsafe abortion is
suspected. In contrast, the effectiveness of routine use of antibiotics prior to
evacuating the uterus in cases of incomplete abortion has not been supported
by adequate studies. May, et. al. cite the paucity of trials comparing a policy
of prophylaxis vs. no prophylaxis.14 The one study that qualified for their
review showed no differences in postabortal infection rates with routine
prophylaxis or control. Poor compliance with antibiotic treatment was also
noted.
5. Hysterotomy is performed in situations where: (a) myometrium is too
thin, (b) cervix is blocked by a fibroid or other uterine anomalies.

Missed Abortion

1. Cervical preparation decreases the length of the uterine evacuation


process. (Level III, Grade A)

Supporting Statements

Preparing the cervix prior to surgical abortion is intended to make the


procedure both easier and safer. Cervical preparation decreases the length of
the abortion procedure; this may become increasingly important with
increasing gestational age, as mechanical dilation at later gestational ages
takes longer and becomes more difficult. Available data do not suggest a
gestational age where the benefits of cervical dilation outweigh the side-
effects, including pain, that women experience with cervical ripening
procedures or the prolongation of the time interval before procedure
completion.

2. Adjuncts to surgical procedures consists of laminaria and other dilators,


intraoperative real time ultrasound and intracervical vasopressin are
acceptable practices. (Level I, Grade A)

Supporting Statements

Options for cervical preparation include osmotic dilators and


pharmacologic agents. Many formulations and regimens are available, and
recommendations from professional organizations vary for the use of
preparatory techniques in women of different ages, parity or gestational age of
the pregnancy. Evidence noted below are from third trimester rather than first
trimester gestations.
Mechanical methods used in missed abortion were developed
originally for use in the third trimester to ripen the cervix or to induce labor.
This includes a variety of catheters and of laminaria tents inserted into the
cervical canal or into the uterus. They have been replaced largely by
pharmacologic agents over time.
Boulvain, et. al. reviewed some 45 studies to determine the effects of
mechanical methods for third trimester cervical ripening or induction of labor
in comparison with placebo/no treatment, prostaglandins (vaginal,
intracervical, misoprostol) and oxytocin.15 The evidence was however
insufficient to evaluate the effectiveness, in terms of likelihood of vaginal
delivery in 24 hours, of mechanical methods compared with placebo/no
treatment or with prostaglandins. Compared with prostaglandins (intracervical,
intravaginal or misoprostol), the risk of hyperstimulation was reduced.
Compared to oxytocin in women with unfavorable cervix, mechanical
methods reduce the risk of cesarean section. There is no evidence to support
the use of extra-amniotic infusion.
Fifty-one studies examined by Kapp, et. al. showed that current
methods of cervical ripening are generally safe, although efficacy and side-
effects between methods vary.16 Adverse events such as cervical laceration or
uterine perforation are uncommon overall in this body of evidence and no
published study has investigated whether cervical preparation impacts these
rare outcomes. Mifepristone 200 mg, osmotic dilators and misoprostol 400 µg
administered either vaginally or sublingually, are the most effective methods
of cervical preparation were included, resulting in 24 different cervical
preparation comparisons.
When compared to placebo, misoprostol (400-600 µg given vaginally
or sublingually), gemeprost, mifepristone (200 or 600 mg), prostaglandin E
and F2 alpha (2.5 mg administered intracervically) demonstrated larger
cervical preparation effects. When misoprostol was compared to gemeprost,
misoprostol was more effective in preparing the cervix and was associated
with fewer gastrointestinal side effects.
For vaginal administration, administration 2 hours prior was less
effective than administration 3 hours prior to the abortion. Compared to oral
misoprostol administration, the vaginal route was associated with significantly
greater initial cervical dilation and lower rates of side effects. However,
sublingual administration 2-3 hours prior to the procedure demonstrated
cervical effects superior to vaginal administration.

3. The use of uterotonics in the form of oxytocic and oxytocin had been well
established as standards in the pharmacologic management of this type.
(Level I, Grade A)

Supporting Statements

Prior to the introduction of prostaglandin agents oxytocin was used as


a cervical ripening agent as well. In 58 studies involving 11,129 women
analyzed by Kelly, et. al. noted that oxytocin alone reduced the rate of
unsuccessful vaginal delivery within 24 hours when compared with expectant
management (8.3% versus 54%, RR 0.16, 95% CI 0.10-0.25) but the cesarean
section rate was increased (10.4% versus 8.9%, RR 1.17, 95% CI 1.01-1.36).17
On the other hand, comparison of oxytocin alone with either intravaginal or
intracervical prostaglandin reveals that the prostaglandin agents probably
overall have more benefits than oxytocin alone.
!
4. In the Philippines, misoprostol is not approved for therapeutic use in
miscarriage. (Level III, Grade C)

Supporting Statements

When misoprostol (600 µg oral or 800 µg vaginal) was compared to


mifepristone (200 mg administered 24 hours prior to procedure), misoprostol
had inferior cervical preparatory effects. Compared to day-prior laminaria
tents, 200 or 400 µg vaginal misoprostol showed no differences in the need for
further mechanical dilation or length of the procedure; similarly, the osmotic
dilators Lamicel and Dilapan showed no differences in cervical ripening when
compared to gemeprost, although gemeprost had cervical effects which were
superior to laminaria tents.
Older prostaglandin regimens (sulprostone, prostaglandin E2 and F2-
alpha) were associated with high rates of gastrointestinal side effects and
unplanned pregnancy expulsions. Few studies reported women's satisfaction
with cervical preparatory techniques.
Dilation and evacuation is the safest technique for mid-trimester
abortion, especially when performed at 13-16 weeks. Laminaria tents are left
in place overnight, and the procedure is performed under paracervical block
with intravenous sedation using low doses of diazepam and fentanyl.
Evacuation is by means of large-bore vacuum cannula system and large ovum
forceps. General anesthesia is avoided because it increases the risk of
perforation and hemorrhage. Adjuncts to dilatation and evacuation are
intraoperative real-time ultrasound, intracervical vasopressin, two days
treatment with laminaria tents, and Hern's technique combining laminaria with
intra-amniotic infusion of urea prior to dilatation and evacuation.

!
References

1. Aleman A, Althabe F, Belizan J, Bergel E. Bed rest during pregnancy for preventing
miscarriage. Cochrane Database Syst Rev 2005.
2. Rumbold A, Middleton P, Crowther CA. Vitamin supplementation for preventing miscarriage.
Cochrane Database Syst Rev 2005, Issue 2. Art. No.: CD004073. DOI:
10.1002/14651858.CD004073.pub2.
3. Haas DM, Ramsey PS. Progestogen for preventing miscarriage. Cochrane Database Syst Rev
2008.
4. Butler C, Kelsberg G, St. Anna L, Crawford P. Clinical inquiries: How long is expectant
management safe in first trimester miscarriage? J Fam Pract 2005;54(10):889-90.
5. Trinder J, Brocklehurst P, Porter R, Read M, Vyas S, Smith L. Management of miscarriage:
expectant, medical, or surgical? Results of randomised controlled trial (miscarriage treatment
(MIST) trial). BMJ. 2006 May 27;332(7552):1235-40. Epub 2006 May 17.
6. Nanda K, Peloggia A, Grimes D, Lopez L, Nanda G. Expectant care versus surgical treatment
for miscarriage. Cochrane Database Syst Rev 2007, Issue 4. Art. No.: CD003518. DOI:
10.1002/14651858.CD003518.pub2
7. Forna F, Gülmezoglu, AM. Surgical procedures to evacuate incomplete abortion. Cochrane
Database Syst Rev 2001, Issue 1.
8. Neilson JP, Gyte GM, Hickey M, Vazquez JC, Dou L. Medical treatments for incomplete
miscarriage (less than 24 weeks). Cochrane Database Syst Rev.2010 Jan 20;(1):CD007223.
9. Prager, Oyer. Second trimester surgical abortion. Clinical Obstet Gynecol 2009;52(2).
10. Kulier R. Geneva Foundation for Medical Education and Research. March 2003.The
Cochrane Collaboration. Wiley, 2010.
11. Kulier R, Cheng L, Fekih A, Hofmeyr GJ, Campana A. Surgical methods for first trimester
termination of pregnancy. Cochrane Database Syst Rev 2001, Issue 4. Art. No.: CD002900.
DOI: 10.1002/14651858.CD002900.
12. Milingos DS, Mathur M, Smith NC, Ashok PW. Manual vacuum aspiration: a safe alternative
for the surgical management of early pregnancy loss. BJOG 2009 Aug;116(9):1268-71.
13. Stubblefield PG. Surgical techniques of uterine evacuation in first- and second-
trimester abortion. Clin Obstet Gynaecol. 1986 Mar;13(1):53-70.
14. May W, Gülmezoglu AM, Ba-Thike K. Antibiotics for incomplete abortion. Cochrane
Database Syst Rev. 2007 Oct 17;(4):CD001779.
15. Boulvain M, Kelly A, Lohse C, Stan C, Irion O. Mechanical methods for induction of labour.
Cochhrane Database Syst Rev. 2001;(4):CD001233.
16. Kapp N, Lohr PA, Ngo TD, Hayes JL. Cervical preparation for first trimester surgical
abortion. Cochrane Database Syst Rev 2010, Issue 2. Art. No.: CD007207. DOI:
10.1002/14651858.CD007207.pub2
17. Kelly AJ, Tan B. Intravenous oxytocin alone for cervical ripening and induction of labor.
Cochrane Database Syst Rev. 2009;(4):CD003246.
18. Alfirevic Z, Kelly AJ, Dowswell T. Intravenous oxytocin alone for cervical ripening and
induction of labour. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD003246.
RECURRENT ABORTION
Definition, Clinical Findings and Diagnosis
Aida V. San Jose, MD and Florentina A. Villanueva, MD

Definition

1. Recurrent spontaneous abortion and recurrent pregnancy loss (RPL) is


defined as three or more consecutive pregnancy losses before 20 weeks from
the last normal period (LMP) or with fetal weights less than 500 grams.1 Most
women with recurrent miscarriage have embryonic or early fetal loss, and the
minority of losses are after 14 weeks.1

2. For patients with history of RPL, the risk of subsequent pregnancy loss is
estimated to be:
24% - after 2 clinically recognized losses
30% - after 3 losses
40-50% - after 4 losses1
Although the definition includes three or more miscarriages, many agree that
evaluation should at least be considered following two consecutive losses.
This is because the risk of subsequent loss after two successive miscarriages is
similar to that following three losses – approximately 30%.

Causes

Paternal Factors

1. Parental chromosomal abnormalities account for only 2-4% of RPL, but


karyotyping evaluation of both parents remain a critical part of evaluation.2
(Level III, Grade B)

2. The chances of carrier status for a balanced structural chromosome


abnormality are dependent on the maternal age at which the second
miscarriage took place, the number of miscarriages, and whether or not the
parents or siblings of the couple with the recurrent miscarriage have had two
or more miscarriages.2 (Level III, Grade B)

Cytogenetic Factors

3. It is advised to carry out karyotyping using Table 1. All women aged up to 34


years at the time of the second miscarriage (this also applies to women with
more miscarriages) should be offered karyotyping.

4. Women aged between 34 and 39 years at the time of the second miscarriage
should be offered karyotyping on the basis of the number of miscarriages
experienced by them personally and the occurrence of two or more
miscarriages in first degree family members, i.e., parents or siblings. In
women of 39 years old or older at the time of the second miscarriage there is
no need to offer karyotyping regardless of the number of miscarriages.
Table 1: Recommendation for Investigations in Couples with Recurrent Miscarriage
Do Don't Evidence Level
Karyotyping of both partners
Woman < 34 years old at the time
X B
of 2nd miscarriage
Woman 34-39 years old at the time Dependent on
of 2nd miscarriage family history
and number of
miscarriages
Woman > 39 years old at the time
of 2nd miscarriage (irrespective of X
the number of miscarriages)
Karyotyping of conceptus X C
Progesterone in luteal phase X B
Thyroid function X C
Glucose X C
Lupus anticoagulant (LAC),
anticardiolipin antibody (ACA),
X B
immunoglobulin G (IgG) and
immunoglobulin M (IgM)
Anti-thrombin (AT), protein C,
protein S, Factor V Leiden,
X* B
prothrombin 20210 G/A mutation,
and Factor VIII
Random homocysteine X B
Determine body mass index (BMI) X B
Determine lifestyle (smoking /
X B
alcohol / coffee)
*Assessment of thrombophilia factors should take place if there is venous thromboembolism in the
woman's medical history and/or if there is a first-degree family member with a known thrombophilia
defect as well as a venous thromboembolism.

Fetal Factors

5. The frequency of cytogenetically abnormal miscarriage tissue from couples


with recurrent miscarriage does not differ from that of an unselected
population with sporadic miscarriage. (Level III, Grade C)

6. Because numerical chromosome abnormalities found in a product of


conception after miscarriage do not carry an increased risk of another
miscarriage, karyotyping the product of the conception does not add value to
the process of finding the underlying factors in a miscarriage and furthermore
has no therapeutic effects.2

Endocrine Factors

7. Corpus luteum insufficiency: There is insufficient evidence in a subsequent


pregnancy after recurrent miscarriage to justify treatment with progesterone or
!-hCG.2 (Level II-1, Grade C)
Supporting Statements

Research has been carried out into the question as to whether women with
recurrent miscarriage who were given !-hCG or progesterone had a reduced
chance of a miscarriage compared to those receiving a placebo or no
treatment. From an analysis of four randomized trials, it appeared that
prescribing !-hCG reduced the chances of a miscarriage, but this conclusion is
mainly based on the results of two methodologically weak studies. The two
methodologically superior studies show no difference in the risk of
miscarriage.

8. Thyroid dysfunction: Assessment of thyroid status in women with recurrent


miscarriage is not indicated. (Level II-2, Grade B)

Supporting Statements

The prevalence of thyroid dysfunction among women with thyroid


disease is low (1-2%). Thyroid disease is not more prevalent in women with
recurrent miscarriage than it is in the general population. In case-control
studies, an increased risk of recurrent miscarriage has been found in women
with thyroid autoantibodies, but it is unclear whether there is a causal link.2

9. Diabetes Mellitus: Screening for diabetes mellitus in asymptomatic women


because of recurrent miscarriage is not recommended.2 (Level III, Grade B)

Supporting Statements

The prevalence of diabetes mellitus in women with recurrent


miscarriage is low (<1%). It has been shown that women with diabetes
mellitus and high HbA1c levels in the first trimester have an increased risk of
miscarriage, and that the risk for well-controlled patients is not increased.

10. Maternal Infection: Infection of the reproductive tract with bacterial, viral,
parasitic, zoonotic, and fungal organisms has been linked theoretically to
pregnancy loss.1 (Level II-1, Grade A)

Supporting Statements

One prospective comparison trial involving 70 patients with RPL


reported no elevations in any markers for present or past infection with C.
trachomatis when compared with controls.
In contrast, a very large, prospective trial has demonstrated a link
between the detection of bacterial vaginosis and history of second-trimester
pregnancy loss among 500 patients with RPL.
Herpes simplex virus (HSV) and human cytomegalovirus (CMV) can
directly infect the placenta and fetus. The resulting villitis and related tissue
destruction may disrupt pregnancy.1
Another theoretic possibility is that infection-associated early
pregnancy loss may result from immunologic activation that occurs in
response to pathologic organisms. A large body of evidence supports the role
of this mechanism in adverse events that occur later in gestation, such as
intrauterine growth restriction, premature rupture of membranes, and preterm
birth. Alternatively, mechanisms that protect the fetus from autoimmune
rejection also may protect virally infected placental cells from recognition and
clearance.2

11. Uterine Factors: Congenital uterine anomalies are associated with recurrent
miscarriages. (Level II-3, Grade B).

Supporting Statements

Comparative research in women with recurrent miscarriage and a


control group show more congenital uterine anomalies in the first group.
The septate uterus, in particular, is associated with early miscarriage.
Uterine septum resection should only take place in a randomized trial.
Retrospective cohort studies suggest a reduced chance of implantation and an
increased risk of miscarriage in in-vitro fertilization (IVF) patients with a
submucosal fibroid but no association with recurrent miscarriage has been
shown.2

12. Immunologic Factors: Patients with RPL should be investigated for possible
antiphospholipid antibody syndrome. (Level III, Grade A)

Supporting Statements

Antiphospholipid antibody syndrome is characterized by recurrent


miscarriage, pregnancy related morbidity (pre-eclampsia and growth
retardation), and/or venous or arterial thrombosis in combination with the
presence of lupus anticoagulant (LAC) or antibodies to cardiolipin (anti-
cardiolipin antibody [ACA], immunoglobulin G [IgG] and immunoglobulin M
[IgM]).1
In order to establish the diagnosis of antiphospholipid antibody
syndrome, it is advisable to carry out the first blood sampling at least 12
weeks after the latest miscarriage and to confirm the laboratory abnormalities
after at least 12 weeks.1

13. Lifestyle: Patients with RPL should be advised on lifestyle modification.


(Level III, Grade B)

Supporting Statements

Advice relating on lifestyle should include: weight loss (in cases of an


increased BMI, smoking cessation, healthy food. Vitamin intake is not
relevant.2

14. Unexplained recurrent miscarriages: In at least half of the couples with


recurrent miscarriage, diagnostic investigations do not provide an underlying
cause and the final diagnosis is unexplained miscarriage or recurrent
miscarriage. (Level III, Grade C)
Supporting Statements

For this group of patients, no effective treatments have been


discovered through randomized trials. The only therapeutic measure that is left
is "tender loving care" care, whereby a successful outcome of the pregnancy is
described in 85%. It is recommended only to carry out new treatments in this
group of patients in a randomized trial context.
Research also provides insight into the success rates based on the
maternal age and the number of previous miscarriages. It is advisable to
discuss this table with the patient and to estimate her individual chances of
success in a subsequent pregnancy.
The contemporary translation of tender loving care in the support of
women with unexplained recurrent miscarriage might consist of the following
advice: Stop smoking, extra attention by an early ultrasound, and
preconceptional intake of folic acid. Psychosocial support is very important
and referring the couple to an Early Pregnancy Unit (EPU) for preconceptional
diagnostic investigations and advice as well as participation in current studies
is also recommended.2

Minimum Care Required

The following is based on the recommendations of the Dutch Society of


Obstetrics and Gynaecology (NVOG) regarding recurrent miscarriage. The
Netherlands: The Dutch Society of Obstetrics and Gynaecology (NVOG); 2007 Aug
06. 20 p.

Table 2: Recommendations for Treatment in Couples with Recurrent Miscarriage


Do Don't Evidence Level
Pre-implantation genetic screening No randomized
(PGS) X controlled trials
(RCTs)
Pre-implantation genetic diagnosis
(PGD) (indication of structural
?* No RCTs
chromosome abnormality in male or
female partner)
Progesterone or !-hCG X B
Correction of uterine anomaly X No RCTs
Anticoagulant treatment (indication
X** B
antiphospholipid syndrome)
Anticoagulant treatment (indication
X B
hereditary thrombophilia factor)
Advise to lose weight X B
Stop smoking X B
Eat healthily X C
Calculate prognosis for subsequent
pregnancy (if unexplained recurrent X B
miscarriage)
References

1. Berek, Jonathan S (Eds). Berek and Novak's Gynecology, 14th Edition. Lippincott Williams
& Wilkins, 2007.
2. The Dutch Society of Obstetrics and Gynaecology (NVOG). Guideline on recurrent
miscarriage. The Netherlands 2007;6:20.
3. Cuningham G, et al (Eds). “Abortion” In: Williams Obstetrics. McGraw-Hill Companies, Inc.
2010.
4. Royal College of Obstetricians and Gynaecologists (RCOG). The management of early
pregnancy loss. Royal College of Obstetricians and Gynaecologists (RCOG) Guideline No.
25. 2006;18.
5. European Society of Human Reproduction and Embryology (ESHRE) Special Interest Group
for Early Pregnancy (SIGEP). Updated and revised nomenclature for description of early
pregnancy events. Human Reproduction 2005;20(11):3008-3011.
6. Gaufberg SV. Early pregnancy loss. Contributor Information and Disclosures. Updated: April
16, 2010.
7. Shields AD. Pregnancy diagnosis. Contributor Information and Disclosures. Updated: April
20, 2009.
8. Bottomley C, Van Belle V, Mukri F, Kirk E, Van Huffel S, Timmerman D, Bourne T. The
optimal timing of an ultrasound scan to assess the location and viability of an early pregnancy.
Human Reproduction 2009;24(8):1811-1817.
9. Stubblefield PG, Grimes DA. Septic abortion. New Engl J Med 1994;331(5): 310-314.
10. Broklehurst TJ, et al. Management of miscarriage: expectant, medical, or surgical? Results of
randomised controlled trial (miscarriage treatment (MIST) trial). Br Med J 2006;332:1235-
1240.
11. Finkielman JD, De Feo FD, Heller PG, Afessa B. The clinical course of patients with septic
abortion admitted to an intensive care unit. Intensive Care Med 2006;30(6).
12. Davis VJ. Induced abortion guidelines. SOGC Clinical Practice Guidelines 2006;184.
13. Chan FY, Ghosh A, Tang M, Ng J. Ultrasound in prenatal diagnosis: use and pitfalls. J Hong
Kong Med Assoc 1991;43(2).
UNSAFE ABORTION
Sybil Lizanne R. Bravo, MD and Lorina Q. Esteban, MD

Definition

1. Induced Abortion – medical or surgical termination of pregnancy before the


time of fetal viability1

2. Unsafe Abortion – a procedure carried out by persons lacking the necessary


skills or in an environment that does not conform to minimal medical
standards, or both2

WHAT IS AN ABORTION LAW?


(Lifted from The Revised Penal Code of the Philippines, AN ACT REVISING THE PENAL
CODE AND OTHER PENAL LAWS)

The basic status of abortion in the Philippines is that it is illegal, or banned by rule of
law.

The act is criminalized by the Revised Penal Code of the Philippines, which was
enacted in 1930 and remains in effect today. Articles 256, 258 and 259 of the Code
mandate imprisonment for the woman who undergoes the abortion, as well as for any
person who assists in the procedure, even if they be the woman's parents, a physician
or midwife. Article 258 further imposes a higher prison term on the woman or her
parents if the abortion is undertaken "in order to conceal [the woman's] dishonor".

There is no law in the Philippines that expressly authorizes abortions in order to save
the woman's life; and the general provisions which do penalize abortion make no
qualifications if the woman's life is endangered. It may be argued that an abortion to
save the mother's life could be classified as a justifying circumstance (duress as
opposed to self-defense) that would bar criminal prosecution under the Revised Penal
Code. However, this has yet to be adjudicated by the Philippine Supreme Court.

Proposals to liberalize Philippine abortion laws have been opposed by the Catholic
Church, and its opposition has considerable influence in the predominantly Catholic
country. However, the constitutionality of abortion restrictions has yet to be
challenged before the Philippine Supreme Court. (see Appendix)

Clinical Manifestations

1. Symptoms1-3
a. fever
b. chills
c. malaise
d. abdominal pain
e. vaginal bleeding
f. passage of placental tissues
2. Signs1,3,4
a. elevated temperature
b. tachycardia
c. tachypnea
d. with sepsis: agitation, patients appears toxic/disoriented
e. lower abdominal tenderness
f. absence of fever with leukemoid reaction (white blood cell [WBC] 45-
120,000/mm")
g. fluid sequestration
h. hypotension
i. edema of infected tissues

3. Abdominopelvic examination
a. most often an open cervix with bleeding and foul smelling products of
conception or discharge
b. cervical/vaginal lacerations
c. open cervix with or without a catheter
d. bimanual examination: uterine tenderness (with or without parametrial
cellulitis or abscess)
e. with gas gangrene of the uterus: crepitation in the pelvis
f. abdominal tenderness, guarding, and rebound, and whether tenderness
is limited to the lower abdomen (pelvic peritonitis) or is present over
the entire abdomen (generalized peritonitis)

Supporting Statements

Infection after abortion is an ascending process that occurs more commonly in


the presence retained products of conception or operative trauma. Uterine perforation
may be followed by severe infection, whether or not there is bowel injury.5
Finkielman, et. al. described the clinical course, complications, and outcome
of patients with septic abortion admitted to the intensive care unit (ICU). The records
of the 63 patients of a university hospital in Argentina between 1985 and 1995 were
reviewed. The mean age of the patients was 28.5 years, and 33% had had previous
abortions. The mean gestational age was 10.5 weeks. The first ICU day Acute
Physiology and Chronic Health Evaluation (APACHE) II mean score was 13.9. Acute
renal failure developed in 73% (46 of 63) of the patients, disseminated intravascular
coagulation (DIC) in 31% (15 of 49), and septic shock in 32% (20 of 63). Blood
cultures were positive in 24% (15 of 62). Twelve patients died (19%). Eight of the
deaths occurred during the first 48 hour of the ICU admission. Compared with
survivors, non-survivors had higher median number of organ failures (1.0 vs 4.0,
p<0.0001), mean first ICU day SOFA scores (6.6 vs 10.0, p=0.0059), and mean
APACHE II scores (12.7 vs 20.2, p=0.0003), and were more likely to have septic
shock (18 vs 92%, p<0.0001), and receive dopamine (37 vs 83%, p=0.0040),
mechanical ventilation (8 vs 83%, p<0.0001), and pulmonary artery catheter (8 vs
41%, p=0.0026). Although it is an avoidable complication, septic abortion requiring
admission to the ICU is associated with high morbidity and mortality.
Diagnosis

1. A complete blood count is necessary in the diagnosis of induced abortion.


(Level III, Grade A)

Supporting Statement

A complete blood count and differential are necessary baselines in the


management of patients with delayed postabortal infection.7-10

2. Swabbing of the endocervix should be done to detect Chlamydia


trachomatis and Neisseria gonorrhea. (Level III, Grade C)

Supporting Statements

The legal termination of pregnancy has introduced its own spectrum of


infectious morbidity. The primary contributing factors are those of omission
or commission. The principal error of omission is the failure to monitor the
patient for occult infection due to Neisseria gonorrhea or Chlamydia
trachomatis. Technical errors like failure to completely evacuate the uterus or
to ensure adequate hemostasis constitute the errors of commission.
Infections due to exogenous virulent pathogens usually occurs within
eight hours or less of the procedure. Due to the action of the group A, C or G
!-hemolytic streptococci, the patients get sick rapidly. Screening for N.
gonorrhea in high risk populations is advisable. Screening for C. trachomatis
should be done for all women.
If the endocervical culture is positive at the time of curettage, the
infection rate for women undergoing operative termination of pregnancy
increases three fold.
Approximately 15% of women harboring the gonococcus at the
endocervix develop postabortal infection.11

3. Submit endometrial tissue specimen for gram stain and culture. (Level
III, Grade C)

Supporting Statements

Gram stain of the endometrium will show mixed flora admixed with
white blood cells. If peritoneal signs are present, baseline tissue culture of the
endometrium is recommended.
Doing sampling of the endometrium and sending it for culture will lead
to identification of the bacterium responsible for the infection. This will be
helpful in managing complicated infections following abortion. The specimen
should be placed in aerobic and anaerobic transport media and sent to the
laboratory for processing.11-12

4. Blood culture should be done in all patients who have: (a) advanced
disease, (b) peritoneal signs, and (3) rigor.11 (Level III, Grade A)
5. Transvaginal ultrasound (TVS) can detect retained secundines or fluid
within the endometrial cavity and myometrial disruption. It can detect
the presence of a pelvic mass and should be obtained if pelvic tenderness
or examination prohibits the performance of adequate examination.
(Level III, Grade A)

Supporting Statement

The presence of foul smelling discharge after legal termination of


pregnancy is suggestive of retained products of conception, which can be
confirmed by TVS.11-12

6. Chest x-ray / Computed tomography (CT) scan / Magnetic resonance


imaging (MRI): These tests are valuable in assessing the entire abdomen
and pelvis for presence of abscesses and in detecting suspected gangrene.
(Level III, Grade C)

Supporting Statements

If peritoneal signs are present or the patient’s condition worsens, a


roentgenogram of the pelvis or a CT scan is indicated. The presence of a gas
pattern in the uterine wall or the pelvis or a localized ileus are indications for
surgical intervention.
A CT scan is useful in assessing the entire abdomen and pelvis for the
presence of abscesses. It may also be used for percutaneous drainage under
direct visualization.11-12

7. Protime / prothrombin time, serum electrolytes, aspartate transaminase


(AST) / alanine transaminase (ALT), blood urea nitrogen (BUN),
creatinine: Liver and kidney function tests should be monitored especially
if there is evidence of systemic deterioration. (Level III, Grade A)

Supporting Statement

Because many antibiotics are excreted by the kidneys and nephrotoxic,


early evaluation of the renal function is important. If there is impaired kidney
function, the dosages of the antibiotics will be adjusted.12

Management

1. Periabortal use of antibiotics in therapeutic abortion has protective effect.


(Level I, Grade A)

Supporting Statements

In a meta-analysis of 12 studies done, there is a substantial protective


effect of antibiotics in all women undergoing therapeutic abortion even though
in low risk groups.
Sawaya, et. al. reported on overall summary relative risk (RR) for
developing postabortal upper genital tract infection in women receiving
prophylactic antibiotic of 0.58 (95% confidence interval [CI] 0.47-0.72)
compared with women receiving placebo. In high risk women (with history of
pelvic inflammatory disease [PID]), there was a summary RR of 0.56 (95% CI
0.37-0.84). In women with no risk factors, the RR was protective at 0.65
(95% CI 0.47-0.90). In summary, the routine use of periabortal antibiotics in
the United States may prevent up to half of all cases of postabortal
infections.13

2. Several antibiotic regimens that have been found to be effective are


recommended. (Level III, GPP)

Supporting Statement

Most patients with postabortion infection due to retained products of


conception respond to combined medical/surgical therapy. A number of
successful parenteral antibiotics have been used. (See algorithm)

3. The antibiotic regimen should be continued until the following sought for
therapeutic response is attained:
a. No temperature equal to or greater than 37.6°C
b. Absence of local physical findings
c. A normal white blood cell count (Level III, Grade A)

Supporting Statements

The need for continued antibiotic treatment once the anticipated


therapeutic response had been met is questionable. The use of ampicillin 500
mg every 6 hours for four to five days has been used for potential medico-
legal rather than serious therapeutic indications. Once the previously defined
therapeutic end titration points are achieved, no further antibiotic therapy is
necessary.11
Unsafe abortions result not only in costs for acute care but may also be
responsible for longer-term complications such as PID, damage to
reproductive organs, and secondary infertility. If effective, antibiotic
prophylaxis at the time of the procedure can potentially prevent these adverse
consequences.
Incomplete abortions cause many complications and the deaths of tens
of thousands of women each year. Women who seek health care after an
incomplete abortion usually come for problems from bleeding too much or
infection. Antibiotics are generally given when there are signs of infection.
The review of trials showed difficulties for women in continuing to take
antibiotics and returning for care, so single dose antibiotics may be more
suitable in these circumstances. The trials did not provide enough evidence to
show the effects of routine antibiotics for women after incomplete abortion.14

4. A transfusion threshold of hemoglobin of 7-9 g/dl is reasonable.15 (Level


III, Grade C)
5. Curettage is recommended if retained secundines are seen on TVS. The
procedure should be done within 4-8 hours after admission. (Level I,
Grade A)

Supporting Statement

There were no reports of maternal deaths in the trials identified.


Vacuum aspiration versus dilatation and curettage: There were no statistically
significant differences for excessive blood loss, blood transfusion, febrile
morbidity, incomplete or repeat uterine evacuation procedure, re-
hospitalization, postoperative abdominal pain or therapeutic antibiotic use.
Duration of operation was statistically significantly shorter with vacuum
aspiration compared to dilatation and curettage in both gestational age
subgroups: < 9 weeks: weighted mean difference (WMD) -1.84 minutes, 95%
CI -2.542 to -1.138); =/> 9 weeks: WMD -0.600 minutes, 95% CI -1.166 to -
0.034.
Flexible versus rigid vacuum aspiration cannula: There were no statistically
significant differences with regard to cervical injuries, febrile morbidity, blood
transfusion, therapeutic antibiotic use, or incomplete or repeat uterine
evacuation procedure.
Manual vacuum aspiration (MVA) versus electrical vacuum aspiration:
Severe pain was reported less often with MVA compared to electrical vacuum
aspiration in women with < 9 weeks of amenorrhea (RR 0.73, 95% CI 0.47-
1.16). In women with amenorrhea > 9 weeks, severe difficulty of the
procedure was reported more frequently with MVA compared to electrical
vacuum aspiration (RR 5.7, 95% CI 2.45-13.28). There was no difference in
cervical injuries, excessive blood loss, blood transfusion, febrile morbidity,
repeat uterine evacuation, duration of operation and women's preference
between the two groups.
Authors' conclusions
Complications for surgical first trimester abortion are rare. The included
studies do not indicate overall benefits of one over the other method. MVA
can be used for early first trimester surgical abortion, but maybe more difficult
when used later in the first trimester. Duration of procedure is shorter with
vacuum aspiration compared to dilatation and curettage, which may be of
importance when using local anesthetics or for busy clinics. Outcomes such as
women's satisfaction, the need for pain relief or surgeon’s preference for the
instrument have been inadequately addressed. No long-term outcomes, such as
fertility after surgical abortion, are available.

6. Vacuum aspiration is a safe and quick treatment for incomplete


abortions. (Level I, Grade A)

Supporting Statements

Two trials were evaluated. Vacuum aspiration was associated with


statistically significantly decreased blood loss (-17 ml WMD, 95% CI -24 to -
10 ml), less pain (RR 0.74, 95% CI 0.61-0.90), and shorter duration of
procedure (-1.2 min WMD, 95% CI -1.5 to -0.87 min), than sharp curettage, in
the single study that evaluated these outcomes. Serious complications such as
uterine perforation and other morbidity were rare and the sample sizes of the
trials were not large enough to evaluate small or moderate differences.17
Authors' conclusions
Vacuum aspiration is safe, quick to perform, and less painful than sharp
curettage, and should be recommended for use in the management of
incomplete abortion. Analgesia and sedation should be provided as necessary
for the procedure.

7. The following are considered indications for exploratory laparotomy:18


a. (+) peritoneal signs and demonstration of gas pattern by x-ray or CT
scan
b. persistent fever > 36 hours after triple therapy and evacuation (Level
III, Grade B)

8. Uterine perforation should be treated empirically with antibiotics when


this diagnosis is being considered and prompt gynecologic consultation
should be obtained. Diagnosis and definitive management are
accomplished with laparoscopy and exploratory laparotomy when
indicated.19 (Level III, Grade B)

9. Properly timed surgery for evacuation of septic products and/or pus and
for repairing damaged bowels is important.20 (Level III, Grade B)
Algorithm for Management of Induced Abortion
(Adopted and modified from POGS Clinical Practice Guidelines on Infectious
Diseases)21

1
after thorough history taking and physical examination
2
severity/grading of abortion (see table below)
3
empiric antimicrobial therapy before shifting to culture-guided treatment
4
alternative choice includes clindamycin for penicillin-allergic patients, and other higher-generation
beta-lactam antibiotics
5
may give anti-tetanus vaccine if insult is within 24 hrs
6
consider exploratory laparotomy if without/poor response to initial antimicrobial therapy or if
high index of suspicion for retained products of conception (or when TVS shows retained
products), or if cannot rule out organ injury
Determining the severity of the condition is critically important in appropriately
prioritizing therapeutic intervention. A scoring mechanism for classification of the
severity of infected abortion modified from Hager (1985) is recommended in the table
below:22

Mild Moderate Severe


(score for each (score for each (score for each
parameter =1) parameter =2) parameter =3)

Low abdominal pain


Cervical motion tenderness
Purulent or foul discharge Scanty profuse
L adnexal mass* Absent present
R adnexal mass* Absent present
L adnexal tenderness
R adnexal tenderness
Temperature 38-390C 39-400C > 400C
Trimester < 12 weeks > 12 weeks
History of instrumentation Suspicion Confirmed
TOTAL SCORE

Interpretation
TOTAL SCORE
Mild <8
Moderate 8-12
Severe >20
Notes:
• The infection is considered “Severe” if any one of the following conditions are
present REGARDLESS OF THE SCORE:
1. Hypotension with tachycardia unless secondary to blood loss
2. Tachypnea (respiratory rate >24)
• Initial response of hypotension and tachycardia to hydration may signify
hypovolemia.
• Presence of bilateral adnexal masses is considered “Severe”.

References

1. American College of Obstetricians and Gynecologists. Induced Abortion. November 2008.


2. Ledger WJ. Infectious complications associated with legal termination of pregnancy. In:
Monif GRG, DA Baker. Infectious Diseases in Obstetrics and Gynecology, 6th Ed, 2008.
3. Postabortion complication, bacteremia, sepsis, and septic shock. In: Sweet RL, Gibbs RS.
Infectious Complications of the Female Genital Tract, 5th Ed, 2009.
4. Lichtenberg ES, Grimes DA, Paul M. Abortal complications: prevention and management.
In: Paul M, et al. A Clinician’s Guide to Medical and Surgical Abortion. New York:
Churchill Livingstone, 1999.
5. Masinde, Gumodoka B. Management of postabortion complication. The Internet J Gynecol
Obstet 2010;12(2).
6. Finkielman JD, De Feo FD, Heller PG, Afessa B. Intensive Care Med 2004 Jun;30(6):1097-
102.
7. Stone CK, Humphries R. Current Diagnosis and Treatment Emergency Medicine. 6th Ed.
East Norwalk, CT: McGraw Hill, 2008.
8. Katz VL. Spontaneous and recurrent abortion: etiology, diagnosis, treatment. In: Katz VL,
Lentz GM, Lobo RA, Gershenson DM (Eds). Comprehensive Gynecology. 5th Ed.
Philadelphia, Pa: Mosby Elsevier, 2007.
9. Simpson JL, Jauniaux ERM. Pregnancy loss. In: Gabbe SG, Niebyl JR, Simpson JL (Eds).
Obstetrics: Normal and Problem Pregnancies. 5th Ed. Philadelphia, Pa: Elsevier Churchill
Livingstone, 2007.
10. Laurino MY, Bennett RL, Saraiya DS, et al. Genetic evaluation and counseling of couples
with recurrent miscarriage: Recommendations of the National Society of Genetic Counselors.
J Genet Couns 2005;14(3).
11. Gilles RG. Monif, David A. Baker. Infectious complications associated with legal termination
of pregnancy. In: Infectious diseases in obstetrics and gynecology. 6th ed 2008.
12. Sebastian F and Soper DF. Infectious diseases in women. Philadelphia: W. B. Saunders
Company, 2001.
13. Sawaya GF, Grady D, Kerliwoske K, Grimes DA. Antibiotics at the time of induced abortion:
the case for universal prophylaxis based on a meta-analysis. Obstet Gynecol 1996;87:884.
14. May W, Gülmezoglu AM, Ba-Thike K. Antibiotics for incomplete abortion. Cochrane
Database Syst Rev 2007, Issue 4. Art. No.: CD001779. DOI: 10.1002/
14651858.CD001779.pub2.
15. Guinn DA, Abel DE, Tomlinson MW. Early goal-directed therapy for sepsis during
pregnancy. Obstet Gynecol Clin N Am 2007;34:459-79.
16. Kulier R, Cheng L, Fekih A, Hofmeyr GJ, Campana A. Surgical methods for first trimester
termination of pregnancy. Cochrane Database of Systematic Reviews 2001, Issue 4. Art. No.:
CD002900. DOI: 10.1002/14651858.CD002900
17. Forna F, Gülmezoglu AM. Surgical procedures to evacuate incomplete miscarriage. Cochrane
Database Syst Rev 2001, Issue 1. Art. No.: CD001993. DOI: 10.1002/14651858.CD001993.
18. Fawad A, et al. Septic induced abortions. J Ayub Med Coll Abbotabad 2008; 20(4).
19. Lynne McCullough. Complications of induced abortion. In: Harwood-Nuss’ Clinical Practice
of Emergency 4th ed. Lippincott Williams & Wilkins 2005.
20. Singh R, Nagrath A, Taneja S. Evaluation of septic abortions over past 6 years in a teaching
hospital. J Obstet Gynecol India 2007;57(1).
21. Philippine Obstetrical and Gynecological Society Clinical Practice Guidelines on Infectious
Diseases, 2009.
22. Hager’s Septic abortion scoring system 1985
23. Centers for Disease Control and Prevention, MMWR 2009 58(SS08);1–35
24. World Health Organization. Unsafe abortion: global and regional estimates of unsafe abortion
and associated mortality in 2000. 2004.
25. Encyclopedia Britannica 2007;26:674.
26. Spitz IM, Bardin CW, Benton L, Robbins A. Early pregnancy termination with mifepristone
and misoprostol in the United States. New Engl J Med 1998;338(18):1241.
27. Healthwise. Manual and vacuum aspiration for abortion. WebMD 2004.
http://www.webmd.com/hw/womens_conditions/tw1078.asp#tw1112
28. World Health Organization. Dilatation and curettage. Managing Complications in Pregnancy
and Childbirth: A Guide for Midwives and Doctors 2003.
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encyclopedia_761553899/Abortion.html. Retrieved 2008-12-05
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32. The Revised Penal Code of the Philippines, AN ACT REVISING THE PENAL CODE AND
OTHER PENAL LAWS
APPENDIX

The Revised Penal Code of the Philippines


AN ACT REVISING THE PENAL CODE AND OTHER PENAL LAWS
Section Two. Infanticide and Abortion.

Art. 255. Infanticide. — The penalty provided for parricide in Article 246 and for
murder in Article 248 shall be imposed upon any person who shall kill any child less
than three days of age. If the crime penalized in this article be committed by the
mother of the child for the purpose of concealing her dishonor, she shall suffer the
penalty of prision correccional in its medium and maximum periods, and if said crime
be committed for the same purpose by the maternal grandparents or either of them,
the penalty shall be prision mayor.

Art. 256. Intentional abortion. — Any person who shall intentionally cause an
abortion shall suffer:

1. The penalty of reclusion temporal, if he shall use any violence upon the
person of the pregnant woman.

2. The penalty of prision mayor if, without using violence, he shall act without
the consent of the woman.

3. The penalty of prision correccional in its medium and maximum periods, if


the woman shall have consented.

Art. 257. Unintentional abortion. — The penalty of prision correccional in its


minimum and medium period shall be imposed upon any person who shall cause an
abortion by violence, but unintentionally.

Art. 258. Abortion practiced by the woman herself of by her parents. — The penalty
of prision correccional in its medium and maximum periods shall be imposed upon a
woman who shall practice abortion upon herself or shall consent that any other person
should do so.

Any woman who shall commit this offense to conceal her dishonor, shall suffer the
penalty of prision correccional in its minimum and medium periods. If this crime be
committed by the parents of the pregnant woman or either of them, and they act with
the consent of said woman for the purpose of concealing her dishonor, the offenders
shall suffer the penalty of prision correccional in its medium and maximum periods.

Art. 259. Abortion practiced by a physician or midwife and dispensing of abortives.


— The penalties provided in Article 256 shall be imposed in its maximum period,
respectively, upon any physician or midwife who, taking advantage of their scientific
knowledge or skill, shall cause an abortion or assist in causing the same. Any
pharmacist who, without the proper prescription from a physician, shall dispense any
abortive shall suffer arresto mayor and a fine not exceeding 1,000 pesos.