IGUBAN, Majoerie S.

Study ObjectiveTo 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

effacesNitric 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 20082 groups:

Group A: 50 participants that used 60 mg ISMN tablet

Group B: 50 participants that used a placebo vit C tablet

Material and MethodsParticipants

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 MethodsCervix- ripe if Bishop score was >6 After 48 hours (or earlier if with any

complaints) assessment of Bishop

scoreo Bishop score ≤6: inpatient cervical ripening

(Misoprostol 25µg q6)o Bishop score >6: oxytocin drip

Material and MethodsFailed 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

DiscussionNO 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.

DiscussionISMN is an effective cervical ripening agent

compared to placeboISMN 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 AppraisalPrimary 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: 0.1Relative Risk: 0.7Relative 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