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

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

Interventions

DRUG

Oral misoprostol

* 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

Oxytocin

* 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.

Sponsors & Collaborators

• Gynuity Health Projects

  collaborator OTHER

• Government Medical College, Nagpur

  collaborator INDUSTRY

• Daga Memorial Women's Hospital, Nagpur, India

  collaborator OTHER

• Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, India

  collaborator UNKNOWN

• University of Liverpool

  lead OTHER

Principal Investigators

• Andrew D Weeks, FRCOG · University of Liverpool

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-06

Primary Completion

2022-07-30

Completion

2022-07-30

Countries

• India

Study Locations