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Complications; Cesarean SectionNCT02587013

Comparison of Uterine Repair Methods for Cesarean Delivery

A study testing Type A of uterine repair: In situ and Type B of uterine repair: Exteriorization in people with Complications; Cesarean Section, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Complications; Cesarean Section
What is being tested?
Type A of uterine repair: In situ and Type B of uterine repair: Exteriorization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteCanada
Study dates
Nov 2015to Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Canada1 site

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec, H1T 2M4

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Type A of uterine repair: In situ, Type B of uterine repair: Exteriorization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Type A of uterine repair: In situProcedure or surgery

    Also called Intra-abdominal uterine repair

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

  • Type B of uterine repair: ExteriorizationProcedure or surgery

    Also called Extra-abdominal uterine repair, Exteriorisation of the uterus

    The uterine incision is repaired with the exteriorization of the uterus

Study groups in NCT02587013
Study groupRoleWhat they receive
In situ uterine repairExperimentalThe uterus is repaired in situ within the abdominal cavity, without exteriorization; intra-abdominal repair
Receives: Procedure: Type A of uterine repair: In situ
Exteriorization of the uterusActive comparatorThe uterine incision is repaired with the exteriorization of the uterus; extra-abdominal repair
Receives: Procedure: Type B of uterine repair: Exteriorization

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Intraoperative

Secondary outcomes (9)

  1. Incidence of hypotension

    Hypotensive episodes, defined as a difference of more than 20% of the baseline mean arterial pressure, despite a phenylephrine infusion

    Measured: Intraoperative

  2. Pelvic irrigation

    To determine if the patient had pelvic irrigation, yes or no

    Measured: Intraoperative

  3. Length of surgery

    Measured: Intraoperative

  4. Estimated blood loss

    Measuring suction canisters and wet sponges

    Measured: Intraoperative

  5. Reduction in hemoglobin

    Difference between preoperative and postoperative hemoglobin within 24 hours of surgery

    Measured: Within 24 hours of surgery

  6. Incidence of endometritis

    Measured: Through study completion; on average of 1 year

  7. 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.

    Measured: Up to 2 weeks

  8. Length of hospital stay after the cesarean delivery

    Measured: Through study completion on average of 1 year

  9. Incidence of tachycardia

    Tachycardia, defined as a heart rate above 100 beats per minute

    Measured: Intraoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2015 (estimated)
  2. Study startNov 2015
  3. Primary completionJul 2018
  4. Study completionJul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02587013
Sponsor's protocol ID
151019
Status last verified
Dec 2018
First submitted
21 Oct 2015
Last updated
17 Dec 2018
Results posted
No
Data monitoring committee
No

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.

    PubMed 32282591

Questions about this trial

What is this clinical trial studying?

A study testing Type A of uterine repair: In situ and Type B of uterine repair: Exteriorization in people with Complications; Cesarean Section, run by Maisonneuve-Rosemont Hospital at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of intraoperative nausea and vomiting (time frame: Intraoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02587013, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2018.

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