Premature Rupture of Membranes With a Bishop Score<6: Comparison of Medical Induction/Expectant Management

NCT02825641 | Completed

• 1 other identifier: 0213-15-RMB
• Study Type: interventional
• Target: 458
• Locations: 1 country
• Sites: 1

Brief Summary

The study is intended to compare expectant management and on presentation labor induction in women with premature rupture of membranes. The means of labor induction and cervical ripening are either oxytocin or dinoprostone. Expectant management in this obstetrical state means waiting 24 hours from the onset of rupture of membranes and then commencing labor induction with either oxytocin or dinoprostone depending on the patient's obstetrical history and cervical condition. The investigators' hypothesis is that active management will lead to a higher rate of vaginal deliveries, a shorter interval between the time of rupture of membranes and the time of delivery, a lower rate of cesarean sections and a better obstetric result for the mother and the fetus/newborn.

Conditions

Medical Induction of Labor Affecting Newborn

Outcome Measures

Primary Outcomes (1)

• Vaginal delivery rate

  The percentage of participants that achieved vaginal delivery

  Up to 7 days from the time of presentation with rupture of membranes

Secondary Outcomes (2)

• Interval to delivery

  Up to 7 days from the time of presentation with rupture of membranes

• Caesarian delivery rate

  Up to 7 days from the time of presentation with rupture of membranes

Study Arms (4)

Expectant Management-Dinoprostone

ACTIVE COMPARATOR

Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score\<6). Labor induction will be initiated with Dinoprostone after 24 hours of waiting depending on obstetric history and cervical conditions.

Drug: Dinoprostone

Expectant Management-Oxytocin

ACTIVE COMPARATOR

Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score\<6). Labor induction will be initiated with oxytocin after 24 hours of waiting depending on obstetric history and cervical conditions.

Drug: Oxytocin

Active Management-Dinoprostone

EXPERIMENTAL

Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score\<6). Labor induction will be initiated with Dinoprostone on presentation depending on obstetric history and cervical conditions.

Drug: Dinoprostone

Active Management-Oxytocin

EXPERIMENTAL

Women with premature rupture of membranes who are not in active labor and have an unfavorable cervix (Bishop score\<6). Labor induction will be initiated with oxytocin on presentation depending on obstetric history and cervical conditions.

Drug: Oxytocin

Interventions

Oxytocin DRUG

Labor induction and cervical ripening by oxytocin in women with premature rupture of membranes in 2 types of women: 1. Induction of labor on presentation at the delivery room. 2. Induction of labor after 24 hours of rupture of membranes.

Also known as: Pitocin

Active Management-Oxytocin; Expectant Management-Oxytocin

Dinoprostone DRUG

Labor induction and cervical ripening by dinoprostone in women with premature rupture of membranes in 2 types of women: 1. Induction of labor on presentation at the delivery room. 2. Induction of labor after 24 hours of rupture of membranes.

Also known as: Cervidil

Active Management-Dinoprostone; Expectant Management-Dinoprostone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Term pregnancies \>37 weeks of gestation.
• Certain rupture of membranes.
• Bishop score \< 6.
• Singleton pregnancies.
• Vertex presentation.
• No obstetric or clinical contraindications for labor induction.
• Reactive non stress test on presentation.

You may not qualify if:

• Previous cesarean section.
• Previous uterine surgeries (Myomectomy etc.).
• Placenta Previa.
• Multiple gestation pregnancies.
• Pregnancies with history of fetal reduction or Intrapartum uterine fetal demise.
• Known fetal defects/Chromosomal abnormalities.
• Active genital Herpes.
• HIV carrier.
• Contractions that are less than 10 minutes apart.

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam health care campus

Haifa, Israel

Location

MeSH Terms

Interventions

Oxytocin; Dinoprostone

Intervention Hierarchy (Ancestors)

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

Study Officials

• Amir Weissman, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: July 7, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2021
• Study Completion: September 30, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)