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Completed

NCT Number: NCT02587013

Comparison of Uterine Repair Methods for 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.

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Key information

Conditions

Complications; Cesarean Section

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Type A of uterine repair: In situ

Procedure

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

Other names: Intra-abdominal uterine repair

Type B of uterine repair: Exteriorization

Procedure

The uterine incision is repaired with the exteriorization of the uterus

Other names: Extra-abdominal uterine repair, Exteriorisation of the uterus

Primary outcomes

  1. Incidence of intraoperative nausea and vomiting

    Time frame: Intraoperative

    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.

Secondary outcomes

  1. Incidence of hypotension

    Time frame: Intraoperative

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

  2. Pelvic irrigation

    Time frame: Intraoperative

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

  3. Length of surgery

    Time frame: Intraoperative

  4. Estimated blood loss

    Time frame: Intraoperative

    Measuring suction canisters and wet sponges

  5. Reduction in hemoglobin

    Time frame: Within 24 hours of surgery

    Difference between preoperative and postoperative hemoglobin within 24 hours of surgery

  6. Incidence of endometritis

    Time frame: Through study completion; on average of 1 year

  7. Time to return of bowel function

    Time frame: Up to 2 weeks

    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.

  8. Length of hospital stay after the cesarean delivery

    Time frame: Through study completion on average of 1 year

  9. Incidence of tachycardia

    Time frame: Intraoperative

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

Sponsors and collaborators

Lead sponsor

Maisonneuve-Rosemont Hospital

Other

Registry information

Official study title

Randomized Controlled Trial of Uterine Exteriorization Versus in Situ Repair for Elective Cesarean Delivery

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 27, 2015
Registry last updated
Dec 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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