NCT02587013

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

December 17, 2018

Status Verified

December 1, 2018

Enrollment Period

2.7 years

First QC Date

October 21, 2015

Last Update Submit

December 14, 2018

Conditions

Complications; Cesarean Section

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Incidence of hypotension

    Intraoperative

  • Pelvic irrigation

    Intraoperative

  • Length of surgery

    Intraoperative

  • Estimated blood loss

    Intraoperative

  • Reduction in hemoglobin

    Within 24 hours of surgery

  • +4 more secondary outcomes

Study Arms (2)

In situ uterine repair

EXPERIMENTAL

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

Procedure: Type A of uterine repair: In situ

Exteriorization of the uterus

ACTIVE COMPARATOR

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

Procedure: Type B of uterine repair: Exteriorization

Interventions

Type A of uterine repair: In situPROCEDURE

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

Also known as: Intra-abdominal uterine repair
In situ uterine repair
Type B of uterine repair: ExteriorizationPROCEDURE

The uterine incision is repaired with the exteriorization of the uterus

Also known as: Extra-abdominal uterine repair, Exteriorisation of the uterus
Exteriorization of the uterus

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective cesarean delivery
  • Term gestation, 37 weeks or more
  • Healthy parturients (ASA 1 and 2)
  • Spinal anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 32282591DERIVED

Study Officials

  • Valerie Zaphiratos, MD

    Maisonneuve-Rosemont Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical associate professor

Study Record Dates

First Submitted

October 21, 2015

First Posted

October 27, 2015

Study Start

November 1, 2015

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

December 17, 2018

Record last verified: 2018-12

Locations

CA(1)