Comparison of Uterine Repair Methods for Cesarean Delivery

Maisonneuve-Rosemont Hospital180 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

180

Conditions

Complications; Cesarean Section

Interventions

Type A of uterine repair: In situPROCEDURE

The uterine incision is closed with the uterus within the abdominal cavity

Type B of uterine repair: ExteriorizationPROCEDURE

The uterine incision is repaired with the exteriorization of the uterus

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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.

Time frame: Intraoperative

Secondary Outcomes

Incidence of hypotension

Hypotensive episodes, defined as a difference of more than 20% of the baseline mean arterial pressure, despite a phenylephrine infusion

Time frame: Intraoperative

Pelvic irrigation

To determine if the patient had pelvic irrigation, yes or no

Time frame: Intraoperative

Length of surgery

Time frame: Intraoperative

Estimated blood loss

Measuring suction canisters and wet sponges

Time frame: Intraoperative

Reduction in hemoglobin

Difference between preoperative and postoperative hemoglobin within 24 hours of surgery

Time frame: Within 24 hours of surgery

Incidence of endometritis

Time frame: 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.

Data from ClinicalTrials.gov

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