Comparison of Uterine Repair Methods for Cesarean Delivery

Complications; Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587013
• Other study ID #: 151019
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: July 2018

Study information

• Verified date: December 2018
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complications; Cesarean Section

Intervention

Procedure:
• Type A of uterine repair: In situ
The uterine incision is closed with the uterus within the abdominal cavity
• Type B of uterine repair: Exteriorization
The uterine incision is repaired with the exteriorization of the uterus

Locations

Country	Name	City	State
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of hypotension	Hypotensive episodes, defined as a difference of more than 20% of the baseline mean arterial pressure, despite a phenylephrine infusion	Intraoperative
Secondary	Pelvic irrigation	To determine if the patient had pelvic irrigation, yes or no	Intraoperative
Secondary	Length of surgery		Intraoperative
Secondary	Estimated blood loss	Measuring suction canisters and wet sponges	Intraoperative
Secondary	Reduction in hemoglobin	Difference between preoperative and postoperative hemoglobin within 24 hours of surgery	Within 24 hours of surgery
Secondary	Incidence of endometritis		Through study completion; on average of 1 year
Secondary	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.	Up to 2 weeks
Secondary	Length of hospital stay after the cesarean delivery		Through study completion on average of 1 year
Secondary	Incidence of tachycardia	Tachycardia, defined as a heart rate above 100 beats per minute	Intraoperative