Management of Prelabor Rupture of the Membranes at Term

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04307069
• Other study ID #: Rambam Health-Care Center
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2024
• Source: Rambam Health Care Campus
• Contact: Gal Bachar, MD
• Phone: +972524858699
• Email: gal.bachar13[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 524
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications
• Chorioamnionitis
• Endometritis
• Fetal Infection
• Rupture

Intervention

Drug:
• Oxytocin
The drug wil be adminisrate for augmentation of labor at admission.

Locations

Country	Name	City	State
Israel	Rambam	Ramat Yishai

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	Maternal infectious morbidity	Maternal chorioamnionitis and/ or endometritis	Up to 48 hours postpartum
Secondary	Length of latent and active phases of labor.	According to vaginal examinations during labor	During Labor
Secondary	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
Secondary	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