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

PHASE4CompletedINTERVENTIONAL
Enrollment

520

Participants

Timeline

Start Date

January 6, 2020

Primary Completion Date

July 30, 2022

Study Completion Date

July 30, 2022

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."

Trial Locations (3)

Unknown

Daga Memorial Women's Hospital, Nagpur

Mahatma Gandhi Institute of Medical Sciences, Sevāgrām

Government Medical College (GMC), Nagpur

All Listed Sponsors
collaborator

Gynuity Health Projects

OTHER

collaborator

Government Medical College, Nagpur

INDUSTRY

collaborator

Daga Memorial Women's Hospital, Nagpur, India

OTHER

collaborator

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

UNKNOWN

lead

University of Liverpool

OTHER

NCT03749902 - A Randomized Trial of Oral Misoprostol Alone Versus Oral Misoprostol Followed by Oxytocin for Labour Induction | Biotech Hunter | Biotech Hunter