Effectiveness of vaginal isosorbide mononitrate for cervical ripening in uncomplicated singleton pregnancies at 39 weeks gestation in an outpatient setting: A randomized controlled trial

Early Phase 1

• Conditions: Induction of labour

• Registration Number: SLCTR/2013/030
• Lead Sponsor: niversity of Ruhuna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 August 2024

Recruitment & Eligibility

• Status: Complete: follow up complete
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

1.Uncomplicated pregnancy at 39 weeks POG
2.Singleton fetus having a cephalic presentation
3. Modified Bishop's Score <5
4.Consenting to self-administer the vaginal tablets every other day for five doses.

Exclusion Criteria

1.Any pregnancy complications e.g. Pregnancy Induced Hypertension, Gestational Diabetes Melitus
2.Multiple pregnancies
3.Planned Caesarean section
4.Fetal Growth Restriction
5.History of hypersensitivity or idiosyncratic reaction to nitrates.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spontaneous Onset Labour (SOL) between 39 weeks and 40 weeks + 2 days<br> [ POG of 40weeks + 2 days.]<br>Mean Modified Bishops Score (MBS) at 40weeks + 2 days [ POG of 40weeks + 2 days.]<br>Change in mean MBS between 39 weeks and 40 weeks + 2 days.<br> [ POG of 40weeks + 2 days.]<br>

Secondary Outcome Measures

Name	Time	Method
Mean MBS at 40 weeks + 6 days. <br> [From 40 week + 2days to post delivery. ]<br>Requirement of Artificial Separation of Membranes and/or vaginal PGE2 and/or intra cervical Foley catheter at 40 weeks + 6 days. [From 40 week + 2days to post delivery. <br>]<br>Requirement of induction of labour with amniotomy and intra venous oxytocin infusion at 41 weeks. [From 40 week + 2days to post delivery. <br>]<br>Mean induction delivery interval. [From 40 week + 2days to post delivery. <br>]<br> Total dose of oxytocin used. [From 40 week + 2days to post delivery. <br>]<br> Mode of delivery [From 40 week + 2days to post delivery. <br>]<br>Side effects (headache, pelvic pain, nausea/vomiting, hot flushes, dizziness and palpitations) [From 40 week + 2days to post delivery. <br>]<br>Maternal satisfaction (using a questionnaire) [From 40 week + 2days to post delivery. <br>]<br>Neonatal outcomes [From the time of delivery up to discharge from the hospital]<br>