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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04307069
Other study ID # Rambam Health-Care Center
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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