Cesarean 123 Trial: Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery

Pregnancy Related Clinical Trial

— C123T  

Official title:

Cesarean 123 Trial: Prospective Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05750394
• Other study ID #: 2023P000041
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: July 2025

Study information

• Verified date: February 2023
• Source: Brigham and Women's Hospital
• Contact: James A. Greenberg, MD
• Phone: 7819101968
• Email: jagreenberg[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare post-operative uterine scar thickness in people who have had the uterus closed during cesarean sections by one of three different methods. The main questions it aims to answer are:

• Residual myometrial thickness at the scar site assessed by MRI performed 4 months after the procedure

• Myometrial niche formation assessed by MRI performed 4 months after the procedure

• Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness

• Post-operative change in hemoglobin

• Time required for hysterotomy closure

• The number of extra sutures required to achieve surgeon-acceptable hemostasis

Participants undergoing scheduled cesarean sections will be randomized to one of three different uterine closure methods. The methods are:

1. Single layer closure using the following technique: Closure of the myometrium and serosa with one barbed suture using a running unlocked technique. The endometrium should be excluded.

2. Double layer closure using the following technique: Closure of the full thickness of the myometrium with one smooth suture using a running locked technique. The endometrium should be excluded. Followed by imbrication of the second layer with one smooth suture using a running unlocked technique.

3. Triple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques: Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture using a running unlocked technique followed by closure of the remaining myometrium and serosa with one barbed suture using a running unlocked technique. Or, Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture on using a running unlocked technique followed by closure of the remaining myometrium with one barbed suture a running unlocked technique followed by closure of the serosa with one barbed suture using a running unlocked technique.

Four months after the surgery, participants will have a MRI of the pelvis to assess the scar on the uterus.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 18 years or older

• Singleton gestation

• Nonurgent primary or secondary cesarean delivery at greater than 35w6d

• Body Mass Index (BMI) <35 kg/m^2

Exclusion Criteria:

• More than 1 prior cesarean delivery

• Multiple gestation

• Known coagulation disorder or current use of anti-coagulants

• Mullerian anomalies

• Placenta previa

Related Conditions & MeSH terms

• Pregnancy Related

Intervention

Procedure:
• Uterine layers closed
Uterus closed with 1, 2 or 3 layers

Device:
• Suture Type
Barbed or smooth

Procedure:
• Endometrium
Included or excluded

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

References & Publications (2)

Alessandri F, Evangelisti G, Centurioni MG, Gustavino C, Ferrero S, Barra F. Fishbone double-layer barbed suture in cesarean section: a help in preventing long-term obstetric sequelae? Arch Gynecol Obstet. 2021 Sep;304(3):573-576. doi: 10.1007/s00404-021- — View Citation

Roberge S, Demers S, Girard M, Vikhareva O, Markey S, Chaillet N, Moore L, Paris G, Bujold E. Impact of uterine closure on residual myometrial thickness after cesarean: a randomized controlled trial. Am J Obstet Gynecol. 2016 Apr;214(4):507.e1-507.e6. doi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myometrial thickness	Residual myometrial thickness at the scar site assessed by MRI performed	4 months
Secondary	Niche	Myometrial niche formation assessed by MRI performed	4 months
Secondary	Scar ratio	Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness by MRI	4 month
Secondary	Blood loss	Post-operative change in hemoglobin	1 day
Secondary	Time for closure	Time required for hysterotomy closure	Immediate
Secondary	Extra sutures	The number of extra sutures required to achieve surgeon-acceptable hemostasis	Immediate