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

Not Applicable

• Conditions: Premature Rupture of Membrane; Prelabor Rupture of Membranes
• Interventions: Drug: Misoprostol; Drug: Oxytocin

• Registration Number: NCT04143685
• Lead Sponsor: sammour.rami

Brief 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.

Study Timeline

• Study First Submitted: 2018-12-19
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-29
• Study Start: 2019-12-01
• Last Update Submitted: 2020-01-27
• Last Update Posted: 2020-01-29
• Primary Completion: 2021-08-01
• Study Completion: 2021-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Women in their 1st - 4th delivery
• Term prelabor rupture of membranes (37+0 to 42+0 gestational age)
• Vertex presentation
• Singleton pregnancy

Exclusion Criteria

• Multiple pregnancy
• Previous cesarean section
• Chorioamnionitis on admission
• >2 symptomatic uterine contractions in 10 minutes
• Prostaglandins hypersensitivity
• Contraindication for vaginal delivery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
misoprostol	Misoprostol	misoprostol 50 mcg tablet by mouth every four hours for maximum dosage of six
oxytocin	Oxytocin	Oxytocin 10 IU in 1000 mL Standard solution. Starting with 10 mL/hr infusion rate and increasing by 10mL/hr every 20 minutes until achieving 3-5 regular uterine contractions every 10 minutes (as recorded by cardiotocography)

Primary Outcome Measures

Name	Time	Method
Vaginal delivery rate	During delivery

Secondary Outcome Measures

Name	Time	Method
Operative delivery rate, Cesarean section rate, time interval from induction of labor to delivery	During delivery
chorioamnionitis rate	During or after delivery up to 7 days	intra-amniotic infection during or after delivery representing in possible combination of maternal fever, fetal tachycardia, maternal leukocytosis, Histopathologic evidence of infection or inflammation or both in the placenta, fetal membranes, or the umbilical cord vessels
Uterine tachysystole	During delivery
Neonatal morbidity	up to 7 days after delivery	Antibiotic administration

Trial Locations

Locations (1)

Bnai Zion Medical Center; 🇮🇱 Haifa, Israel