Comparison of Uterine Repair Methods for Cesarean Delivery

Not Applicable

Completed

• Conditions: Complications; Cesarean Section

• Registration Number: NCT02587013
• Lead Sponsor: Maisonneuve-Rosemont Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2015-10-21
• Study First Submitted QC: 2015-10-23
• Study First Posted: 2015-10-27
• Study Start: 2015-11
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-14
• Last Update Posted: 2018-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of intraoperative nausea and vomiting	Intraoperative	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.

Secondary Outcome Measures

Name	Time	Method
Length of surgery	Intraoperative
Incidence of hypotension	Intraoperative	Hypotensive episodes, defined as a difference of more than 20% of the baseline mean arterial pressure, despite a phenylephrine infusion
Reduction in hemoglobin	Within 24 hours of surgery	Difference between preoperative and postoperative hemoglobin within 24 hours of surgery
Pelvic irrigation	Intraoperative	To determine if the patient had pelvic irrigation, yes or no
Estimated blood loss	Intraoperative	Measuring suction canisters and wet sponges
Incidence of endometritis	Through study completion; on average of 1 year
Time to return of bowel function	Up to 2 weeks	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.
Length of hospital stay after the cesarean delivery	Through study completion on average of 1 year
Incidence of tachycardia	Intraoperative	Tachycardia, defined as a heart rate above 100 beats per minute

Trial Locations

Locations (1)

Maisonneuve-Rosemont Hospital; 🇨🇦 Montreal, Quebec, Canada