NCT04143685

Labor Induction With Misoprostol Versus Oxytocin in Women With Premature Rupture of Membranes

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: sammour.rami · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study compares the rate of vaginal delivery after induction of labor with misoprostol versus oxytocin in women with prelabor rupture of membranes. Participants will be randomized to receive either oral misoprotsol every four hours until going into labor, or intravenous oxytocin in increasing dose.

Detailed description

Misoprostol is a synthetic prostaglandin analogue commonly used for labor induction. It causes uterine contractions and ripening of the cervix. Oxytocin sold under the brand name Pitocin among others, is a medication made from the peptide oxytocin and is used to cause contraction of the uterus to start labor. This randomized controlled trial will compare induction of labor in women with term premature rupture of the membranes and unripe cervix using misoprostol versus oxytocin. The primary outcome is the rate of vaginal delivery. Secondary outcomes will include cesarean section rate, time interval from induction of labor to delivery, neonatal morbidity, patient satisfaction and side effects, as well as chorioamnionitis.

Conditions

• Prelabor Rupture of Membranes
• Premature Rupture of Membrane

Interventions

Type	Name	Description
DRUG	Misoprostol	Oral administration of cytotec every 4 hours until a maximum of 6 doses
DRUG	Oxytocin	Intravenous infusion of Pitocin through an IVAC until delivery

Timeline

• Start date: 2019-12-01
• Primary completion: 2021-08-01
• Completion: 2021-10-01
• First posted: 2019-10-29
• Last updated: 2020-01-29

Locations

1 site across 1 country: Israel