Status:
COMPLETED
Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage
Lead Sponsor:
Baylor Research Institute
Conditions:
Postpartum Hemorrhage
Uterine Atony
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The objective of the study is to demonstrate whether cooling the uterine smooth muscle during cesarean section (following delivery of the fetus) will promote better uterine contraction and involution ...
Detailed Description
Study Design: Patients will be randomly assigned to either the study group or the control group. Patients may receive regional (epidural or spinal/epidural) or general anesthesia.Initially, the inves...
Eligibility Criteria
Inclusion
- Pregnant adult women of any gravidity, and gestational duration who present for cesarean section at Baylor University Medical Center in Dallas and who have given informed consent to be in the study.
Exclusion
- Women who refuse to be in the study, and women who are unable to consent due to emergent nature of the cesarean section will be excluded. Women who are unable to understand the nature of the study due to mental illness, mental retardation, medical condition, or other communication barrier will be excluded.
- Inability to exteriorize the uterus during c-section.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT02229513
Start Date
July 1 2013
End Date
August 1 2014
Last Update
January 19 2018
Active Locations (1)
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1
Baylor University Medical Center
Dallas, Texas, United States, 75246