Management of Prelabor Rupture of the Membranes at Term

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fetal Infection, Chorioamnionitis, Endometritis, Cesarean Section Complications

Intervention / Treatment
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* Drug: Oxytocin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primiparous women with a singleton pregnancy that are admitted with prelabor rupture of membranes. Women at gestational age 370/7 or more. Vertex presentation. Exclusion Criteria: Age 18 and under. High order gestation. Women with contraindication for a vaginal delivery. Active labor. Documented fetal anomalies. Known or suspected intrauterine infection (temperature > 38 degrees, leucocytosis). Non reassuring fetal heart rate tracing. Positive group B streptococcus status.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate oxytocin infusion<br>Once the patient will arrive at the maternity ward with prelabor rupture of membranes, she will receive oxytocin for augmentation of labor. | Drug: Oxytocin<br>* The drug wil be adminisrate for augmentation of labor at admission.<br>* Other names: pitocin;|
| Experimental: Expectant management for 24 hours<br>Once the patient will arrive at the maternity ward with prelabor rupture of membranes, we will wait for spontaneous delivery to occur. After 24 hours of rupture of membranes, the woman will receive oxytocin for augmentation of labor. | Drug: Oxytocin<br>* The drug wil be adminisrate for augmentation of labor at admission.<br>* Other names: pitocin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal infectious morbidity | Maternal chorioamnionitis and/ or endometritis | Up to 48 hours postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of latent and active phases of labor. | According to vaginal examinations during labor | 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). | 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. | Up to 48 hours postpartum |