Postpartum Hemorrhage Clinical Trial
Official title:
Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage: A Randomized Controlled Trial
Verified date | December 2015 |
Source | Baylor Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 resulting in lower blood loss, use of fewer uterotonic medications, and fewer hysterectomies following cesarean section. The investigators suspect that it may.
Status | Completed |
Enrollment | 200 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | Baylor University Medical Center | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient Temperature | Pre-op, Intra-op, Post-Op | ||
Other | Total Time Uterus Wrapped | During hysterotomy repair | ||
Other | Uterine Temperature After Wrap Removed | Immediately following hysterotomy repair | ||
Primary | Blood Loss | At the conclusion of the surgery, blood loss will be calculated by measuring the content of blood in the suction canister, and by weighing the surgical sponges. The amount of blood loss in the PACU will be measured by weighing pads. | During surgery and in the PACU (approximately 3 total hours) | |
Secondary | Change in Pre- vs Post-operative Hematocrit | 48 hours post operative period | ||
Secondary | Use of Uterotonic Medications | During surgery and in the PACU (approximately 3 total hours) | ||
Secondary | Use of Extra Oxytocin | Intraoperatively | ||
Secondary | Use of Methergine | Intraoperatively | ||
Secondary | Use of Hemabate | Intraoperatively | ||
Secondary | Use of Cytotec | Intraoperatively | ||
Secondary | Bakri Bulb Placement | Intraoperatively | ||
Secondary | Use of Additional Measures to Control Blood Loss, Including Pharmacological and Surgical Interventions | Intraoperatively | ||
Secondary | Requirement of Blood Products | During surgery and in the PACU (approximately 3 total hours) | ||
Secondary | Total Blood Loss Greater Than 1000 cc | Intra-op, Post-Op | ||
Secondary | Requirement of Cesarean Hysterectomy | During surgery and in the PACU (approximately 3 total hours) |
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