MISOBEST - Orally Misoprostol Solution (Cytotec®) Versus Orally Misoprostol as a Tablet (Angusta®) for Induction of Labor

PHASE3CompletedINTERVENTIONAL
Enrollment

884

Participants

Timeline

Start Date

January 21, 2022

Primary Completion Date

December 31, 2022

Study Completion Date

May 21, 2023

Conditions
Induced Vaginal Delivery
Interventions
DRUG

Misoprostol

Women presenting at the study site with an indication for IOL will receive written and oral information about the study. They will have the opportunity to ask questions. If the woman agrees to participate and is deemed eligible, she will sign informed consent. The Swedish national guidelines regarding the method of IOL will be followed. Women will have an abdominal palpation to exclude malpresentation, a CTG, and a digital cervical exam to establish bishop score (BS) prior to inclusion (as per clinical practice). Randomization will be performed by the attending physician, midwife or study coordinator. Randomization will be by opening numbered opaque sealed envelopes in sequential order containing the randomization code. There are no restrictions for use of other medications. All concomitant medication will be recorded in the CRF.

Trial Locations (1)

118 83

Södersjukhuset, Stockholm

All Listed Sponsors
lead

Karolinska Institutet

OTHER