Management of Prelabor Rupture of the Membranes at Term

Comparison Between Two Protocols for Management of Prelabor Rupture of the Membranes at Term

Prolonged rupture of membranes has been associated with increased risk of chorioamnionitis and endometritis. In this study the investigators will investigate whether an early intervention to augment labor with oxytocin is superior to expected management for spontaneous delivery (up to 24 hours).

Study Overview

• Status: Recruiting
• Conditions: Chorioamnionitis; Cesarean Section Complications; Endometritis; Fetal Infection
• Intervention / Treatment: Drug: Oxytocin

Detailed Description

Prelabor rupture of the membranes (PROM) refers to rupture of the fetal membranes prior to the onset of regular uterine contractions.

PROM at term can be managed actively by induction of labor or expectantly by waiting for the onset of a spontaneous labor. Several studies have shown an association between expectant management and higher rates of maternal and neonatal adverse outcomes, especially infections. Furthermore, expectant management has been shown to increase the risk for cesarean deliveries (CD), chronic lung disease, cerebral palsy and neonatal mortality. It is suggested that the risk for those complications increase proportionally with the longer the duration of ruptured membranes. Others disagree with those associations.

In this study the investigators will investigate whether early administration of oxytocin is superior to expectant management of 24 hours in patients with PROM at term, in terms of time to delivery and maternal and neonatal adverse outcomes, regardless of bishop score.

• Study Type: Interventional
• Enrollment (Estimated): 524
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gal Bachar, MD; Phone Number: +972524858699; Email: gal.bachar13@gmail.com

Study Locations

• Israel
  • Ramat Yishai, Israel, 3009500
    • Recruiting
    • Rambam
    • Contact: Gal Bachar; Phone Number: 0524858699

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Primiparous women with a singleton pregnancy that are admitted with prelabor rupture of membranes.
2. Women at gestational age 370/7 or more.
3. Vertex presentation.

Exclusion Criteria:

1. Age 18 and under.
2. High order gestation.
3. Women with contraindication for a vaginal delivery.
4. Active labor.
5. Documented fetal anomalies.
6. Known or suspected intrauterine infection (temperature > 38 degrees, leucocytosis).
7. Non reassuring fetal heart rate tracing.
8. Positive group B streptococcus status.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate oxytocin infusion; Once the patient will arrive at the maternity ward with prelabor rupture of membranes, she will receive oxytocin for augmentation of labor.	Drug: Oxytocin; The drug wil be adminisrate for augmentation of labor at admission.; Other Names: pitocin
Experimental: Expectant management for 24 hours; Once the patient will arrive at the maternity ward with prelabor rupture of membranes, we will wait for spontaneous delivery to occur. After 24 hours of rupture of membranes, the woman will receive oxytocin for augmentation of labor.	Drug: Oxytocin; The drug wil be adminisrate for augmentation of labor at admission.; Other Names: pitocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal infectious morbidity	Maternal chorioamnionitis and/ or endometritis	Up to 48 hours postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of latent and active phases of labor.	According to vaginal examinations during labor	During Labor
Adverse maternal outcome	infectious (chorioamnionitis/endometritis), serious maternal morbidity and mortality (death, cardiac arrest, respiratory arrest, ICU admission), post-partum hemorrhage (PPH), obstetric anal sphincter injuries (OASIS).	Up to 48 hours postpartum
Adverse neonatal outcome	stillbirth, infectious disease (sepsis, meningitis, pneumonia), 5-minute Apgar score < 7, umbilical artery pH < 7.0, NICU admission, RDS, use of mechanical ventilation, NEC.	Up to 48 hours postpartum

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Investigators: Principal Investigator: Gal Bachar, MD, Rambam Medical Health Center

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: March 11, 2020
• First Posted (Actual): March 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases; Wounds and Injuries; Adnexal Diseases; Fetal Diseases; Pregnancy Complications; Fetal Membranes, Premature Rupture; Obstetric Labor Complications; Placenta Diseases; Pelvic Inflammatory Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Chorioamnionitis; Rupture; Endometritis; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin
• Other Study ID Numbers: Rambam Health-Care Center

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No