Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-01-15 @ 2:58 PM
Study NCT ID:
NCT03749902
Status:
COMPLETED
Last Update Posted:
2024-12-18
First Post:
2018-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Trial of Oral Misoprostol Alone Versus Oral Misoprostol Followed by Oxytocin for Labour Induction
Sponsor:
University of Liverpool
Organization:
Study Overview
Official Title:
A Randomized Trial Comparing Oral Misoprostol Alone with Oral Misoprostol Followed by Oxytocin in Women Induced for Hypertension of Pregnancy
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOLI
Brief Summary:
The primary objective of the trial is to assess the following: In women who have undergone cervical preparation with oral misoprostol as part of labour induction for hypertensive disease in India, is augmentation using oral misoprostol superior to the standard protocol of intravenous oxytocin?
Detailed Description:
Every year approximately 30 000 women die from hypertensive disease in pregnancy. Magnesium sulphate and anti-hypertensives reduce morbidity, but delivery is the only cure. Low dose oral misoprostol, a prostaglandin E1 analogue, is a highly effective method for labour induction. Usually, once active labour has commenced, the misoprostol is replaced with an intravenous oxytocin infusion. However, some studies have shown that oral misoprostol can be continued into active labour. In the Cochrane review on labour induction, those whose augmentation was continued with misoprostol (M/M protocol) had 42% less CSs than those who changed to oxytocin (M/Ox protocol; 15% vs 26%). This misoprostol-only protocol would be simpler and probably more acceptable to women. However, these two protocols have never been directly compared. We propose a pragmatic, open-label, randomised trial to compare an M/M labour induction protocol with the standard M/Ox protocol.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: