Comparison of Uterine Repair Methods for Cesarean Delivery

Maisonneuve-Rosemont Hospital

Status: Completed

Conditions: Complications; Cesarean Section

Treatments: Procedure: Type B of uterine repair: Exteriorization; Procedure: Type A of uterine repair: In situ

Study type: Interventional

Funder types: Other

Identifiers

NCT02587013

151019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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180 participants in 2 patient groups

In situ uterine repair

Experimental group

Description:

The uterus is repaired in situ within the abdominal cavity, without exteriorization; intra-abdominal repair

Treatment:

Procedure: Type A of uterine repair: In situ

Exteriorization of the uterus

Active Comparator group

Description:

The uterine incision is repaired with the exteriorization of the uterus; extra-abdominal repair

Treatment:

Procedure: Type B of uterine repair: Exteriorization