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

NCT03749902 | Completed Phase 4 DMC

• 1 other identifier: 4007
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 3

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?

Conditions

Induction of Labor

Keywords

preeclampsia; misoprostol; oxytocin

Outcome Measures

Primary Outcomes (1)

• Caesarean birth

  Rate of caesarean birth in the treatment arm

  At delivery

Study Arms (2)

Oxytocin infusion

OTHER

* Oxytocin infusion will be given through an electronic infusion pump. One unit of oxytocin will be injected in 500 mL of Ringer's lactate, started at a rate of 2 mU/min, and increased every 30 min by 2 mU/min until there are three to four contractions every 10 min. The rate will be titrated to maintain that contraction frequency. The maximum dose will be 20mU/min as oxytocin summary product characteristics. * The oxytocin group will not receive misoprostol after the membranes have ruptured.

Drug: Oxytocin

Oral misoprostol

OTHER

* An initial dose of misoprostol 25mcg will be given orally after randomisation (this must be a minimum of 2 hours after the previous misoprostol dose). * The next dose of oral misoprostol will be omitted if moderate or strong contractions are occurring at 3 in 10 minutes or more (i.e. 9 or more in the preceding 30 minutes) * If contractions subsequently reduce to less than 3 in 10 (under 9 in 30 minutes), or become irregular or mild, then the oral misoprostol 25mcg can be restarted * In the event of inadequate progress, clinicians will be advised to give further misoprostol if there are any concerns about contractions strength or frequency.

Drug: Oral misoprostol

Interventions

Oral misoprostol DRUG

* An initial dose of misoprostol 25mcg will be given orally after randomisation (this must be a minimum of 2 hours after the previous misoprostol dose). * The next dose of oral misoprostol will be omitted if moderate or strong contractions are occurring at 3 in 10 minutes or more (i.e. 9 or more in the preceding 30 minutes) * If contractions subsequently reduce to less than 3 in 10 (under 9 in 30 minutes), or become irregular or mild, then the oral misoprostol 25mcg can be restarted * In the event of inadequate progress, clinicians will be advised to give further misoprostol if there are any concerns about contractions strength or frequency.

Also known as: Misoprost

Oral misoprostol

Oxytocin DRUG

* Oxytocin infusion will be given through an electronic infusion pump. One unit of oxytocin will be injected in 500 mL of Ringer's lactate, started at a rate of 2 mU/min, and increased every 30 min by 2 mU/min until there are three to four contractions every 10 min. The rate will be titrated to maintain that contraction frequency. The maximum dose will be 20mU/min as oxytocin summary product characteristics. * The oxytocin group will not receive misoprostol after the membranes have ruptured.

Also known as: Pitocin

Oxytocin infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ongoing pregnancies with a live fetus who require induction because of preeclampsia or hypertensionWomen will be included irrespective of whether an intrapartum caesarean birth on fetal grounds would be considered or not
• Women age ≥18 years
• Signed informed consent form
• Undergone cervical ripening with misoprostol if cervix initially unfavourable
• Decision to augment labour for inadequate uterine contractions despite ruptured membranes (either artificial or spontaneous as part of the induction process)s

You may not qualify if:

• Women with previous caesarean births
• Those unable to give informed consent
• Cervical ripening with agents other than misoprostol (e.g. Foley catheter, prostaglandins)
• Multiple pregnancy
• History of allergy to misoprostol
• Adequate uterine activity
• Pre- induction Ruptured amniotic membranes
• Frank chorioamnionitis (systemic illness with purulent vaginal discharge and uterine tenderness)

Sponsors & Collaborators

• University of Liverpool: lead
• Gynuity Health Projects: collaborator
• Government Medical College, Nagpur: collaborator
• Daga Memorial Women's Hospital, Nagpur, India: collaborator
• Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, India: collaborator

Study Sites (3)

Daga Memorial Women's Hospital

Nagpur, Maharashtra, India

Location

Mahatma Gandhi Institute of Medical Sciences

Sevāgrām, Maharashtra, India

Location

Government Medical College (GMC)

Nagpur, India

Location

Related Publications (3)

• 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.

  PMID: 40437451 DERIVED

• 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.

  PMID: 37759174 DERIVED

• 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.

  PMID: 34325670 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Misoprostol; Oxytocin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Andrew D Weeks, FRCOG

  University of Liverpool

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 21, 2018
• Study Start: January 6, 2020
• Primary Completion: July 30, 2022
• Study Completion: July 30, 2022
• Last Updated: December 18, 2024

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be released upon publication of the trial results. After this, the data will be shared on a public database to maximise the viability of the data.
• Access Criteria: Initially this will be upon request with later public publication of the data.

Locations

IN (3)