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

NCT ID: NCT02825641

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 458 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-01
• Study Completion Date: 2022-09-30

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.

Detailed Description

In the setting of premature rupture of membranes in term pregnancies, it is customary in women who are not in active labor to wait for 24 hours before attempting to induce labor. The means of labor induction used at our medical center are either intravenous oxytocin or per-vaginal dinoprostone, depending on patient's obstetric history and cervical conditions.

The investigators hypothesize that commencing induction of labor at presentation in these women by either means of induction will lead to higher rates of vaginal delivery, shorter intervals between the time of onset of rupture of membranes and the time of delivery and lower rates of cesarean sections.

The participants in the study, upon signing informed consents, will be randomized to 4 groups-2 groups of expectant management in which labor induction will be commenced after 24 hours with either oxytocin or dinoprostone and 2 groups of active management in which labor induction will be commenced at presentation with either oxytocin or dinoprostone.

The participants will be followed from the time of presentation with rupture of membranes at the delivery room and until the time of delivery.

Further obstetric, clinical and demographic information will be acquired from the patient's electronic medical file for analysis accuracy and sub-analysis.

Conditions

Medical Induction of Labor Affecting Newborn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Expectant Management-Dinoprostone

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.

Group Type: ACTIVE_COMPARATOR

Dinoprostone

Intervention Type: 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.

Expectant Management-Oxytocin

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.

Group Type: ACTIVE_COMPARATOR

Oxytocin

Intervention Type: 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.

Active Management-Dinoprostone

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.

Group Type: EXPERIMENTAL

Dinoprostone

Intervention Type: 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.

Active Management-Oxytocin

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.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: 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.

Interventions

Oxytocin

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.

Intervention Type: DRUG

Dinoprostone

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.

Intervention Type: DRUG

Other Intervention Names

Pitocin; Cervidil

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

ROY LAUTERBACH MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amir Weissman, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam Health Care Campus

Locations

Rambam health care campus

Haifa, , Israel

Countries

Israel

Other Identifiers

0213-15-RMB

Identifier Type: -

Identifier Source: org_study_id