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

Primary Purpose

Medical Induction of Labor Affecting Newborn

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Oxytocin
Dinoprostone
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Medical Induction of Labor Affecting Newborn

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Rambam health care campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Experimental

Experimental

Arm Label

Expectant Management-Dinoprostone

Expectant Management-Oxytocin

Active Management-Dinoprostone

Active Management-Oxytocin

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Vaginal delivery rate
The percentage of participants that achieved vaginal delivery

Secondary Outcome Measures

Interval to delivery
Interval from the time of onset of premature rupture of membranes and the time of delivery (In minutes)
Caesarian delivery rate
The percentage of participants that required caesarian delivery

Full Information

First Posted
June 6, 2016
Last Updated
October 24, 2022
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT02825641
Brief Title
Premature Rupture of Membranes With a Bishop Score<6: Comparison of Medical Induction/Expectant Management
Official Title
Premature Rupture of Membranes at Term With an Unfavorable Cervix (Bishop Score<6): Comparison of Oxytocin, Dinoprostone Induction and Expectant Management
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
November 1, 2021 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medical Induction of Labor Affecting Newborn

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
458 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Expectant Management-Dinoprostone
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Expectant Management-Oxytocin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Active Management-Dinoprostone
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Management-Oxytocin
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
Labor induction and cervical ripening by oxytocin in women with premature rupture of membranes in 2 types of women: Induction of labor on presentation at the delivery room. Induction of labor after 24 hours of rupture of membranes.
Intervention Type
Drug
Intervention Name(s)
Dinoprostone
Other Intervention Name(s)
Cervidil
Intervention Description
Labor induction and cervical ripening by dinoprostone in women with premature rupture of membranes in 2 types of women: Induction of labor on presentation at the delivery room. Induction of labor after 24 hours of rupture of membranes.
Primary Outcome Measure Information:
Title
Vaginal delivery rate
Description
The percentage of participants that achieved vaginal delivery
Time Frame
Up to 7 days from the time of presentation with rupture of membranes
Secondary Outcome Measure Information:
Title
Interval to delivery
Description
Interval from the time of onset of premature rupture of membranes and the time of delivery (In minutes)
Time Frame
Up to 7 days from the time of presentation with rupture of membranes
Title
Caesarian delivery rate
Description
The percentage of participants that required caesarian delivery
Time Frame
Up to 7 days from the time of presentation with rupture of membranes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Weissman, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rambam health care campus
City
Haifa
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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