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

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.

Study Overview

• Status: Unknown
• Conditions: Premature Rupture of Membrane; Prelabor Rupture of Membranes
• Intervention / Treatment: Drug: Misoprostol; Drug: Oxytocin

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Bnai Zion Medical Center
    • Contact: Rami Sammour, MD; Phone Number: +97248359052; Email: rsammour2002@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: misoprostol; misoprostol 50 mcg tablet by mouth every four hours for maximum dosage of six	Drug: Misoprostol; Oral administration of cytotec every 4 hours until a maximum of 6 doses; Other Names: Cytotec; PGE1
Active Comparator: 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)	Drug: Oxytocin; Intravenous infusion of Pitocin through an IVAC until delivery; Other Names: Pitocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Vaginal delivery rate	During delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative delivery rate, Cesarean section rate, time interval from induction of labor to delivery		During delivery
chorioamnionitis rate	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	During or after delivery up to 7 days
Uterine tachysystole		During delivery
Neonatal morbidity	Apgar score, , ,	After delivery until discharge
Neonatal morbidity	Umbilical Cord Blood Gases	immediately after delivery
Neonatal morbidity	NICU admission	up to 7 days after delivery
Neonatal morbidity	Antibiotic administration	up to 7 days after delivery

Collaborators and Investigators

• Sponsor: sammour.rami

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: PROM
• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Rupture; Premature Birth; Fetal Membranes, Premature Rupture; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Oxytocin; Misoprostol
• Other Study ID Numbers: MISOX-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No