Cesarean Section Complications Clinical Trial
Official title:
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).
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. |
Country | Name | City | State |
---|---|---|---|
Israel | Rambam | Ramat Yishai |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus |
Israel,
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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