Status:
UNKNOWN
Oxytocin in Cesarean Delivery
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Post Partum Hemorrhage
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
In this study the investigators hypothesize that infused combinations of oxytocin and ergometrine will exhibit fewer cardiac and neurological side effects than equipotent infusion of oxytocin alone. I...
Detailed Description
Obstetric hemorrhage is associated with severe maternal morbidityש and maternal death. The use of tocotonic drugs following delivery is routine practice as part of the active management of the third s...
Eligibility Criteria
Inclusion
- 80 healthy women presenting for elective repeat cesarean delivery under regional anesthesia.
- All women are ASA class 1-2, aged 18 - 45, with body weight 60-100 kg.
Exclusion
- Obstetric risk factors: Pre-eclampsia, abnormalities of placentation (eg placenta accrete, placenta previa), amnionitis, multiple gestation, preterm delivery (\< 37 completed weeks), more than three previous cesarean deliveries, previous history of ante-partum or post-partum hemorrhage.
- Maternal medical risk factors: Chronic hypertension, cardiac disease, intracranial pathology, known allergies to oxytocin or ergometrine, autoimmune disorders, SLE, coagulation defect or anticoagulation therapy, amnionitis.
- Women asking for cord blood donations are not included in this study due to the long elapsed time between delivery and the commencement of oxytocin.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2011
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01236482
Start Date
November 1 2010
End Date
May 1 2011
Last Update
November 8 2010
Active Locations (1)
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1
Hadassah Hebrew University Medical Center
Jerusalem, Israel, 93510