N/A
N=200
Uterine Cooling During Cesarean Delivery to Reduce Blood Loss and Incidence of Postpartum Hemorrhage
Postpartum Hemorrhage · Uterine Atony
Bottom Line
View on ClinicalTrials.gov: NCT02229513 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Blood Loss — 616; 418; 141; 106 cc
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Uterine Cooling (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Baylor Research Institute
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Loss |
616; 418; 141; 106; 756; 536 | — |
| SECONDARY Change in Pre- vs Post-operative Hematocrit |
4.3; 4.8 | — |
| SECONDARY Use of Uterotonic Medications |
5; 4; 95; 96 | — |
| SECONDARY Use of Extra Oxytocin |
1; 1; 99; 99 | — |
| SECONDARY Use of Methergine |
2; 2; 98; 98 | — |
| SECONDARY Use of Hemabate |
1; 2; 99; 98 | — |
| SECONDARY Use of Cytotec |
4; 3; 96; 97 | — |
| SECONDARY Bakri Bulb Placement |
3; 0; 97; 100 | — |
| SECONDARY Use of Additional Measures to Control Blood Loss, Including Pharmacological and Surgical Interventions |
6; 5; 94; 95 | — |
| SECONDARY Requirement of Blood Products |
2; 3; 98; 97 | — |
| SECONDARY Total Blood Loss Greater Than 1000 cc |
21; 9; 79; 91 | — |
| SECONDARY Requirement of Cesarean Hysterectomy |
0; 0; 100; 100 | — |
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 resulting in lower blood loss, use of fewer uterotonic medications, and fewer hysterectomies following cesarean section. The investigators suspect that it may.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02229513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.