Management of Prelabor Rupture of the Membranes at Term
NCT ID: NCT04307069
Last Updated: 2024-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
524 participants
INTERVENTIONAL
2020-05-01
2024-05-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Immediate oxytocin infusion
Once the patient will arrive at the maternity ward with prelabor rupture of membranes, she will receive oxytocin for augmentation of labor.
Oxytocin
The drug wil be adminisrate for augmentation of labor at admission.
Expectant management for 24 hours
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.
Oxytocin
The drug wil be adminisrate for augmentation of labor at admission.
Interventions
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Oxytocin
The drug wil be adminisrate for augmentation of labor at admission.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Women at gestational age 370/7 or more.
3. Vertex presentation.
Exclusion Criteria
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.
18 Years
45 Years
FEMALE
No
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Principal Investigators
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Gal Bachar, MD
Role: PRINCIPAL_INVESTIGATOR
Rambam Medical Health Center
Locations
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Rambam
Ramat Yishai, , Israel
Countries
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Central Contacts
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Facility Contacts
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Gal Bachar
Role: primary
Other Identifiers
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Rambam Health-Care Center
Identifier Type: -
Identifier Source: org_study_id
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