Cesarean Section Complications, Chorioamnionitis, Endometritis, Fetal Infection
Conditions
Brief 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).
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.
Interventions
DRUGOxytocin
The drug wil be adminisrate for augmentation of labor at admission.
Sponsors
Rambam Health Care Campus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal infectious morbidity | Up to 48 hours postpartum | Maternal chorioamnionitis and/ or endometritis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of latent and active phases of labor. | During Labor | According to vaginal examinations during labor |
| Adverse maternal outcome | Up to 48 hours postpartum | infectious (chorioamnionitis/endometritis), serious maternal morbidity and mortality (death, cardiac arrest, respiratory arrest, ICU admission), post-partum hemorrhage (PPH), obstetric anal sphincter injuries (OASIS). |
| Adverse neonatal outcome | Up to 48 hours postpartum | stillbirth, infectious disease (sepsis, meningitis, pneumonia), 5-minute Apgar score \< 7, umbilical artery pH \< 7.0, NICU admission, RDS, use of mechanical ventilation, NEC. |
Countries
Israel
Contacts
Primary ContactGal Bachar, MD
Outcome results
None listed