drugset / Trial / NCT03749902
A Randomized Trial of Oral Misoprostol Alone Versus Oral Misoprostol Followed by Oxytocin for Labour Induction
Phase 4
Completed
520 enrolled
University of Liverpool
Daga Memorial Women's Hospital, Nagpur, India · collabGovernment Medical College, Nagpur · collabGynuity Health Projects · collabMahatma Gandhi Institute of Medical Sciences · collab
RandomizedParallel-groupOpen-labelTreatment
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?
Timeline
- Start
- 2020-01-06
- Primary completion
- 2022-07-30
- Completion
- 2022-07-30
Publications
- Patel A, Howard R, Faragher B, Durocher J, Winikoff B, Symon A, Weeks A, Mundle S, Lightly K. Evaluating women's experiences and satisfaction with labour induction in India: a comparison of the participant generated experience and satisfaction (PaGES) index with standard methods. BMC Pregnancy Childbirth. 2025 May 28;25(1):619. doi: 10.1186/s12884-025-07731-9.
- Symon A, Lightly K, Howard R, Mundle S, Faragher B, Hanley M, Durocher J, Winikoff B, Weeks A. Introducing the participant-generated experience and satisfaction (PaGES) index: a novel, longitudinal mixed-methods evaluation tool. BMC Med Res Methodol. 2023 Sep 28;23(1):214. doi: 10.1186/s12874-023-02016-1.
- Bracken H, Lightly K, Mundle S, Kerr R, Faragher B, Easterling T, Leigh S, Turner M, Alfirevic Z, Winikoff B, Weeks A. Oral Misoprostol alone versus oral misoprostol followed by oxytocin for labour induction in women with hypertension in pregnancy (MOLI): protocol for a randomised controlled trial. BMC Pregnancy Childbirth. 2021 Jul 29;21(1):537. doi: 10.1186/s12884-021-04009-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Misoprostol | Other / unclassified | 25 ug | Oral |
| Subject | Oxytocin | Peptide | — | Intravenous |
Indications
No indication recorded.