Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women

NCT07608874 | Not Yet Recruiting

• 1 other identifier: StudyKSBHAM001
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

Brief Summary

This study compares two ways of closing the uterus during cesarean delivery. In one group, the decidual layer near the uterine cavity is included in the suture. In the other group, this layer is left out. The study will examine whether these two methods differ in how well the uterine scar heals 6 to 9 months after surgery. Women having an elective cesarean delivery will be randomly assigned to one of the two closure methods. Scar healing will be assessed by ultrasound after delivery. The goal is to determine whether one method is associated with better cesarean scar healing and fewer scar defects.

Conditions

Isthmocele; Cesarean Scar Diverticula

Keywords

isthmocele; Uterine closure techniques; Decidual inclusion; Decidual sparing; Cesarean section; Scar thickness; Niche formation; Sonography; Dyspareunia

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with a cesarean scar niche measured by ultrasound

  Presence of a cesarean scar niche, defined as a myometrial indentation at the cesarean scar site with a depth of at least 2 mm, assessed by postoperative ultrasound. The outcome will be reported as the proportion of participants with a niche in each treatment group.

  6 to 9 months post-operation

Secondary Outcomes (17)

• Operative time

  Periprocedural

• Need for additional sutures for hemostasis

  Periprocedural

• Length of hospital stay

  Postoperative day 2

• Postoperative pain intensity on the 11-point Numeric Rating Scale

  Postoperative day 2

• Postoperative bleeding

  Postoperative day 2

Study Arms (2)

Decidual Inclusion Closure

EXPERIMENTAL

Participants randomized to this arm will undergo elective cesarean delivery with single-layer, non-locked uterine closure in which the cavum-near decidual layer at the uterotomy margin is included in the suture. All other operative steps will be performed according to the standardized study protocol.

Procedure: Single-Layered Non-Locked Closure with Decidual Inclusion

Decidual Sparing Closure

EXPERIMENTAL

Participants randomized to this arm will undergo elective cesarean delivery with single-layer, non-locked uterine closure in which the cavum-near decidual layer at the uterotomy margin is excluded from the suture. All other operative steps will be performed according to the standardized study protocol.

Procedure: Single-Layered Non-Locked Closure with Decidual Sparing

Interventions

Single-Layered Non-Locked Closure with Decidual Inclusion PROCEDURE

During the cesarean section, the uterine incision is closed with a single-layered, non-locked suture. In this technique, the decidua (the uterine lining) is included in the closure. This means that the endometrial cells are part of the suture, potentially influencing the healing process of the uterine scar. Goal: The idea is that including the decidua may promote better healing and scar formation, reducing the risk of complications such as isthmocele and improving long-term uterine health.

Decidual Inclusion Closure

Single-Layered Non-Locked Closure with Decidual Sparing PROCEDURE

Procedure: In this technique, the uterine incision is also closed using a single-layered non-locked suture, but the decidua is excluded from the closure. The suture is placed only through the myometrium (muscle layer) of the uterus, leaving the decidua out of the scar tissue. Goal: The intent is to observe if sparing the decidua results in better scar healing and a lower risk of isthmocele formation, as well as fewer long-term complications.

Decidual Sparing Closure

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female pregnant women who are receiving a cesarean section.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton, term pregnancy
• Elective cesarean section before labor onset or membrane rupture
• Maternal age \>18 years
• Ability to provide informed consent

You may not qualify if:

• Placenta previa
• Maternal substance abuse or infection
• Suspected placenta accreta
• Diabetes
• one or more prior cesarean section
• Vulnerable participants (e.g., mental health conditions)
• Emergency cesarean sections

Sponsors & Collaborators

• Kantonsspital Baden: lead

Study Sites (1)

Kantonsspital Baden

Baden, Canton of Aargau, 5400, Switzerland

Location

MeSH Terms

Conditions

Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Amr S. Hamza, Assoc. Prof.

  Kantonsspital Baden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amr S. Hamza, Assoc. Prof.

CONTACT

+41564863513; amr.hamza@ksb.ch

Leonhard Schaeffer, Prof.

CONTACT

+41564863506; leonhard.schaeffer@ksb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: May 27, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 30, 2029
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)