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

Medical Induction of Labor Affecting Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825641
• Other study ID #: 0213-15-RMB
• Status: Completed
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: September 30, 2022

Study information

• Verified date: October 2022
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 458
• Est. completion date: September 30, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Medical Induction of Labor Affecting Newborn
• Rupture

Intervention

Drug:
• Oxytocin
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.
• Dinoprostone
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.

Locations

Country	Name	City	State
Israel	Rambam health care campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal delivery rate	The percentage of participants that achieved vaginal delivery	Up to 7 days from the time of presentation with rupture of membranes
Secondary	Interval to delivery	Interval from the time of onset of premature rupture of membranes and the time of delivery (In minutes)	Up to 7 days from the time of presentation with rupture of membranes
Secondary	Caesarian delivery rate	The percentage of participants that required caesarian delivery	Up to 7 days from the time of presentation with rupture of membranes