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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02825641
Enrollment
458
Registered
2016-07-07
Start date
2016-08-01
Completion date
2022-09-30
Last updated
2022-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical Induction of Labor Affecting Newborn

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.

Interventions

DRUGOxytocin

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.

DRUGDinoprostone

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.

Sponsors

Rambam Health Care Campus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Vaginal delivery rateUp to 7 days from the time of presentation with rupture of membranesThe percentage of participants that achieved vaginal delivery

Secondary

MeasureTime frameDescription
Interval to deliveryUp to 7 days from the time of presentation with rupture of membranesInterval from the time of onset of premature rupture of membranes and the time of delivery (In minutes)
Caesarian delivery rateUp to 7 days from the time of presentation with rupture of membranesThe percentage of participants that required caesarian delivery

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026