Comparison of Uterine Repair Methods for Cesarean Delivery

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

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.

Study Overview

• Status: Completed
• Conditions: Complications; Cesarean Section
• Intervention / Treatment: Procedure: Type A of uterine repair: In situ; Procedure: Type B of uterine repair: Exteriorization

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 Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Maisonneuve-Rosemont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maisonneuve-Rosemont Hospital

Publications and helpful links

General Publications

• Mireault D, Loubert C, Drolet P, Tordjman L, Godin N, Richebe P, Zaphiratos V. Uterine Exteriorization Compared With In Situ Repair of Hysterotomy After Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2020 May;135(5):1145-1151. doi: 10.1097/AOG.0000000000003821.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): July 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: October 21, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Actual): December 17, 2018
• Last Update Submitted That Met QC Criteria: December 14, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 151019