Trials / Completed
CompletedNCT02587013
Comparison of Uterine Repair Methods for Cesarean Delivery
Randomized Controlled Trial of Uterine Exteriorization Versus in Situ Repair for Elective Cesarean Delivery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 180 (actual)
- Sponsor
- Maisonneuve-Rosemont Hospital · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study is designed to compare the exteriorization of the uterus versus the in situ repair for closure of the hysterotomy incision with a completely standardized anesthetic protocol.
Detailed description
Two well-known uterine repair techniques are described; the uterus can be repaired in situ within the peritoneal cavity (intraabdominal) or exteriorized temporarily from the abdomen for the closure of the hysterotomy incision (extraabdominal). 3 meta-analysis on the topic were unable to demonstrate the superiority of one technique regarding maternal morbidities. However, there is a paucity of studies with a standardized anesthetic protocol evaluating these outcomes. This study will evaluate the impact of the uterine repair technique on different maternal morbidities; focusing on intra-operative nausea and vomiting under a standardized anesthetic protocol.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Type A of uterine repair: In situ | The uterine incision is closed with the uterus within the abdominal cavity |
| PROCEDURE | Type B of uterine repair: Exteriorization | The uterine incision is repaired with the exteriorization of the uterus |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2018-07-01
- Completion
- 2018-07-01
- First posted
- 2015-10-27
- Last updated
- 2018-12-17
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02587013. Inclusion in this directory is not an endorsement.