Double-layer Versus Purse Uterine Closure Techniques : Impact on Residual Myometrial Thickness After Cesarean

Uterine Scar Defect Clinical Trial

Official title:

Double-layer Versus Purse Uterine Closure Techniques : Impact on Residual Myometrial Thickness After Cesarean

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04871022
• Other study ID #: UTuniselmanar3
• Status: Completed
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2022
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are different surgical techniques of uterine closure during cesarean. Currently data suggest that the double layer unlocked closure technique is associated with better uterine scar healing, and this technique is considered the gold standard.

This study compares two techniques of uterine closure on myometrium thickness:

1. Double layer unlocked suture;

2. Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium.

The primary outcome is the mean residual myometrium thickness at the site of the uterine scar evaluated by transvaginal ultrasound at six months after cesarean.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: July 1, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

Inclusion Criteria:

• Planned cesarean

• Primary cesarean

• = 38 gestational weeks

Exclusion Criteria:

• Previous cesarean

• Women < 18 years old

• Multiple gestation

• Mullerian anomalies

• Active labor

• Diabetes

• BMI >35 kg/m2

• Placenta praevia

• Chronic systemic disease

• Covid-19 infection

Related Conditions & MeSH terms

• Uterine Scar Defect

Intervention

Procedure:
• Double layer closure of the hysterotomy
Double layer closure with a first continuous unlocked suture of the deep portion of the myometrium and a second unlocked continuous suture that approximate the upper portion of the myometrium.
• Purse closure of the hysterotomy
Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium

Locations

Country	Name	City	State
Tunisia	University hospital Mongi Slim la Marsa	Tunis	La Marsa

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual myometrium thickness		6 months after intervention
Secondary	Operative time		Same day of intervention: day 1
Secondary	Estimated blood loss		Same day of intervention: day 1
Secondary	Mean number of haemostatic sutures		Same day of intervention: day 1
Secondary	scar width		Same day of intervention: day 1