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).
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
524
The drug wil be adminisrate for augmentation of labor at admission.
Rambam
Ramat Yishai, Israel
RECRUITINGMaternal infectious morbidity
Maternal chorioamnionitis and/ or endometritis
Time frame: Up to 48 hours postpartum
Length of latent and active phases of labor.
According to vaginal examinations during labor
Time frame: 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).
Time frame: 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.
Time frame: Up to 48 hours postpartum
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