Status:
COMPLETED
Postpartum Hemorrhage Prevention in Patients With Preeclampsia (PHP3 Study)
Lead Sponsor:
University of Colorado, Denver
Conditions:
Preeclampsia
Eligibility:
FEMALE
13-45 years
Phase:
EARLY_PHASE1
Brief Summary
Evaluation of the efficacy of postpartum 24 hour oxytocin infusion to reduce blood loss in patients with pre-eclampsia (PE)
Detailed Description
The overall goal of this study is to evaluate the efficacy of postpartum 24 hour oxytocin infusion as a prevention-oriented strategy to reduce blood loss in patients with pre-eclampsia (PE) in a blind...
Eligibility Criteria
Inclusion
- vaginal or cesarean delivery at a gestational age greater than or equal to 20 weeks gestational age;
- diagnosis of preeclampsia (PE defined using standard definitions based on the ACOG bulletin and the NIH Working Group on High Blood Pressure in Pregnancy (i.e., a systolic blood pressure greater than 140 mm Hg or a diastolic blood pressure greater than 90 mm Hg on at least 2 occasions at least 6 hours apart after 20 weeks gestation and proteinuria of \> 300mg per 24 hour period or \> 1+ on dipstick).
- patients treated with magnesium sulfate for 24 hours post partum at 2g/hr (standard of care when deemed appropriate by clinician for seizure prophylaxis)
Exclusion
- abnormal placentation (previa, accreta, etc)
- antenatal hemorrhage
- contraindication to oxytocin
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2019
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT02221830
Start Date
February 1 2015
End Date
July 17 2019
Last Update
May 7 2021
Active Locations (1)
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1
University of Colorado Clinical and Translational Research Center
Aurora, Colorado, United States, 80045