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

NCT04143685 | Unknown

• 1 other identifier: MISOX-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Prelabor Rupture of Membranes; Premature Rupture of Membrane

Keywords

PROM

Outcome Measures

Primary Outcomes (1)

• Vaginal delivery rate

  During delivery

Secondary Outcomes (7)

• 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

• Uterine tachysystole

  During delivery

• Neonatal morbidity

  After delivery until discharge

• Neonatal morbidity

  immediately after delivery

Study Arms (2)

misoprostol

ACTIVE COMPARATOR

misoprostol 50 mcg tablet by mouth every four hours for maximum dosage of six

Drug: Misoprostol

oxytocin

ACTIVE COMPARATOR

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

Interventions

Misoprostol DRUG

Oral administration of cytotec every 4 hours until a maximum of 6 doses

Also known as: Cytotec, PGE1

misoprostol

Oxytocin DRUG

Intravenous infusion of Pitocin through an IVAC until delivery

Also known as: Pitocin

oxytocin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• sammour.rami: lead

Study Sites (1)

Bnai Zion Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

Fetal Membranes, Premature Rupture

Interventions

Misoprostol; Alprostadil; Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Prostaglandins E; Fatty Acids, Monounsaturated; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Obstetrics

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: October 29, 2019
• Study Start: December 1, 2019
• Primary Completion: August 1, 2021
• Study Completion: October 1, 2021
• Last Updated: January 29, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)