Comparison of Uterine Repair Methods for Cesarean Delivery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial of Uterine Exteriorization Versus in Situ Repair for Elective Cesarean Delivery

Conditions
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Complications; Cesarean Section

Intervention / Treatment
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* Procedure: Type A of uterine repair: In situ
* Procedure: Type B of uterine repair: Exteriorization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective cesarean delivery Term gestation, 37 weeks or more Healthy parturients (ASA 1 and 2) Spinal anesthesia Exclusion Criteria: Conditions at risk of uterine atony and/or postpartum hemorrhage (multiple gestation, placenta accrete / previa, pre-eclampsia / eclampsia, uterine leiomyomata, polyhydramnios) Morbid obesity (BMI > 35 kg / m2) at delivery Coagulopathy Active labor Cardiomyopathy Emergency cesarean section Refusal/Inability to consent Language other than English or French

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In situ uterine repair<br>The uterus is repaired in situ within the abdominal cavity, without exteriorization; intra-abdominal repair | Procedure: Type A of uterine repair: In situ<br>* The uterine incision is closed with the uterus within the abdominal cavity<br>* Other names: Intra-abdominal uterine repair;|
| Active Comparator: Exteriorization of the uterus<br>The uterine incision is repaired with the exteriorization of the uterus; extra-abdominal repair | Procedure: Type B of uterine repair: Exteriorization<br>* The uterine incision is repaired with the exteriorization of the uterus<br>* Other names: Exteriorisation of the uterus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraoperative nausea and vomiting | Incidence of intraoperative nausea and vomiting using a scale of 0 to 3; 0 being no nausea, 1 being light nausea, 2 being severe nausea, and 3 being nausea accompanied with vomiting and / or retching. The patients will be questioned at 5 pre-determined time points during the cesarean delivery. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypotension | Hypotensive episodes, defined as a difference of more than 20% of the baseline mean arterial pressure, despite a phenylephrine infusion | Intraoperative | 
| Pelvic irrigation | To determine if the patient had pelvic irrigation, yes or no | Intraoperative | 
| Length of surgery |  | Intraoperative | 
| Estimated blood loss | Measuring suction canisters and wet sponges | Intraoperative | 
| Reduction in hemoglobin | Difference between preoperative and postoperative hemoglobin within 24 hours of surgery | Within 24 hours of surgery | 
| Incidence of endometritis |  | Through study completion; on average of 1 year | 
| Time to return of bowel function | The return of bowel function will be assessed by listening to each of the four abdominal quadrants for intestinal peristalsis with a stethoscope twice a day and by assessing the time of the first gas or bowel movement. The first occurrence of any of these events will determine the return of intestinal transit. | Up to 2 weeks | 
| Length of hospital stay after the cesarean delivery |  | Through study completion on average of 1 year | 
| Incidence of tachycardia | Tachycardia, defined as a heart rate above 100 beats per minute | Intraoperative |