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Comparison of Uterine Repair Methods for Cesarean Delivery

NCT ID: NCT02587013

Last Updated: 2018-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-07-31

Brief Summary

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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

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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.

Conditions

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Complications; Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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In situ uterine repair

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

Group Type EXPERIMENTAL

Type A of uterine repair: In situ

Intervention Type PROCEDURE

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

Exteriorization of the uterus

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

Group Type ACTIVE_COMPARATOR

Type B of uterine repair: Exteriorization

Intervention Type PROCEDURE

The uterine incision is repaired with the exteriorization of the uterus

Interventions

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Type A of uterine repair: In situ

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

Intervention Type PROCEDURE

Type B of uterine repair: Exteriorization

The uterine incision is repaired with the exteriorization of the uterus

Intervention Type PROCEDURE

Other Intervention Names

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Intra-abdominal uterine repair Extra-abdominal uterine repair Exteriorisation of the uterus

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Maisonneuve-Rosemont Hospital

OTHER

Sponsor Role lead

Responsible Party

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Valerie Zaphiratos

Clinical associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Valerie Zaphiratos, MD

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital

Locations

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Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 32282591 (View on PubMed)

Other Identifiers

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151019

Identifier Type: -

Identifier Source: org_study_id