Clinical trial NCT02587013: Comparison of Uterine Repair Methods for Cesarean Delivery
Official title: Randomized Controlled Trial of Uterine Exteriorization Versus in Situ Repair for Elective Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications; Cesarean Section
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of intraoperative nausea and vomiting
timeFrame: Intraoperative
Secondary outcomes:
measure: Incidence of hypotension
timeFrame: Intraoperative
measure: Pelvic irrigation
timeFrame: Intraoperative
measure: Length of surgery
timeFrame: Intraoperative
measure: Estimated blood loss
timeFrame: Intraoperative
measure: Reduction in hemoglobin
timeFrame: Within 24 hours of surgery
measure: Incidence of endometritis
timeFrame: Through study completion; on average of 1 year
measure: Time to return of bowel function
timeFrame: Up to 2 weeks
measure: Length of hospital stay after the cesarean delivery
timeFrame: Through study completion on average of 1 year
measure: Incidence of tachycardia
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Valerie Zaphiratos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.