Clinical trial NCT02825641: 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
Overall status: COMPLETED
Phase: NA
Conditions: Medical Induction of Labor Affecting Newborn
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 458
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Vaginal delivery rate
timeFrame: Up to 7 days from the time of presentation with rupture of membranes
Secondary outcomes:
measure: Interval to delivery
timeFrame: Up to 7 days from the time of presentation with rupture of membranes
measure: Caesarian delivery rate
timeFrame: Up to 7 days from the time of presentation with rupture of membranes
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Amir Weissman, MD
role: PRINCIPAL_INVESTIGATOR
References: