A Randomized Trial of Oral Misoprostol Alone Versus Oral Misoprostol Followed by Oxytocin for Labour Induction — MOLI  

Induction of Labor Clinical Trial

Official title: A Randomized Trial Comparing Oral Misoprostol Alone With Oral Misoprostol Followed by Oxytocin in Women Induced for Hypertension of Pregnancy

Status Completed

Clinical Trial 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?

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Induction of Labor

• NCT number: NCT03749902
• Study type: Interventional
• Source: University of Liverpool
• Status: Completed
• Phase: Phase 4
• Start date: January 6, 2020
• Completion date: July 30, 2022