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Completed

NCT Number: NCT02825641

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

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rambam health care campus

Haifa, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oxytocin

Drug

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.

Other names: Pitocin

Dinoprostone

Drug

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.

Other names: Cervidil

Primary outcomes

  1. Vaginal delivery rate

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

    The percentage of participants that achieved vaginal delivery

Secondary outcomes

  1. Interval to delivery

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

    Interval from the time of onset of premature rupture of membranes and the time of delivery (In minutes)

  2. Caesarian delivery rate

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

    The percentage of participants that required caesarian delivery

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Registry information

Official study title

Premature Rupture of Membranes at Term With an Unfavorable Cervix (Bishop Score<6): Comparison of Oxytocin, Dinoprostone Induction and Expectant Management

Important dates

Study start
2016
Primary completion
2021
Study completion
2022
First posted
Jul 7, 2016
Registry last updated
Oct 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.