IGUBAN, Majoerie S.

Study Objective
To determine
whether


60 mg
administered
vaginally is
effective for
preinduction
cervical ripening
on an outpatient
basis
Isosorbide
mononitrate (ISMN)
Background
Ripening- cervix softens, dilates, and effaces
Nitric oxide (NO) NO synthetase (NOS)
3 isoforms
Neuronal
Inducible
Endothelial
Ideal: induce ripening without causing contractions

Material and Methods
Karnataka Institute of Medical Sciences, Hubli
November 2007 to October 2008
2 groups:
Group A: 50 participants that used 60 mg ISMN tablet
Group B: 50 participants that used a placebo vit C
tablet
Material and Methods
Participants
100 patients with various indications for induction of
labor with unripe cervix
pregnant women between 37 and 43 weeks AOG
Singleton pregnancy with fetus in cephalic
presentation
Unfavorable cervix
willing to participate in the study
Materials and Methods
Cervix- ripe if Bishop score was >6
After 48 hours (or earlier if with any complaints)
assessment of Bishop score
o Bishop score 6: inpatient cervical ripening (Misoprostol
25g q6)
o Bishop score >6: oxytocin drip



Material and Methods
Failed labor induction: <4cm cervical dilation and
90% effacement or at least 5 cm (regardless of
effacement) after a minimum of 12-18 hours of
membrane rupture and oxytocin administration
Results

Results

Results

Results

Discussion
NO donors were tried for the first time before surgical
evacuation of the first trimester pregnancy in the form
of vaginal tablet by Thomson et al and intracerically by
Arteaga-Troncoso et al.
Discussion
ISMN is an effective cervical ripening agent compared
to placebo
ISMN group:
spontaneous labor
Bishop score at 48-hour
decrease further ripening
shorter admission to delivery interval

Conclusion
Use of NO donors such as ISMN for
induction of cervical ripening at
term was more effective than
placebo
Critical Appraisal
Primary validity guidelines:

1. Was the assignment of patients to treatment
randomized?
Yes, randomized stratified was used.

2. Were all patients who entered the trial properly
accounted for and attributed at its conclusion?

a)Was follow up complete?
Yes, all patients were assessed accordingly.

b) Were patients analyzed in the groups to which
they were randomized?
Yes.


Secondary validity guidelines:

1. Were the patients, clinicians, and study
personnel blind to the treatment?
No. the patient was aware of the study. Part of the
inclusion criteria is the willingness of the patients
to participate in the study.

2. Were the groups similar at the start of the
trial?
Yes. No significant differences were found
between the intervention and control groups
at baseline.

3. Aside from the experimental intervention,
were the groups treated equally?
Yes.



How large was the treatment effect?

Absolute risk reduction: 0.1
Relative Risk: 0.7
Relative risk reduction: 0.3 (30 %)
Can this be applied to my patient care?
Yes

Were all clinically important outcomes considered?
Yes. The use of ISMN was proven to be effective as a
cervical ripening agent in an outpatient basis

Are the likely treatment benefits worth the potential harm
and costs?
Yes