Trials / Recruiting
RecruitingNCT04307069
Management of Prelabor Rupture of the Membranes at Term
Comparison Between Two Protocols for Management of Prelabor Rupture of the Membranes at Term
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 524 (estimated)
- Sponsor
- Rambam Health Care Campus · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Oxytocin | The drug wil be adminisrate for augmentation of labor at admission. |
Timeline
- Start date
- 2020-05-01
- Primary completion
- 2024-05-01
- Completion
- 2024-05-01
- First posted
- 2020-03-13
- Last updated
- 2024-04-12
Locations
1 site across 1 country: Israel
Source: ClinicalTrials.gov record NCT04307069. Inclusion in this directory is not an endorsement.