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

Kantonsspital Baden

Status: Not yet enrolling

Conditions: Isthmocele; Cesarean Scar Diverticula

Treatments: Procedure: Single-Layered Non-Locked Closure with Decidual Sparing; Procedure: Single-Layered Non-Locked Closure with Decidual Inclusion

Study type: Interventional

Funder types: Other

Identifiers

NCT07608874

StudyKSBHAM001

Details and patient eligibility

About

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.

Full description

Cesarean scar defects, also referred to as niches or isthmoceles, are associated with gynecologic symptoms and adverse outcomes in subsequent pregnancies. The effect of uterine closure technique on scar healing remains uncertain, particularly with regard to whether the cavum-near decidual layer should be included in or excluded from the suture during cesarean closure.

This study is a prospective, randomized, controlled trial comparing two approaches to single-layer, non-locked uterine closure during elective cesarean delivery: decidual inclusion and decidual sparing. In both study groups, all operative steps are standardized except for the handling of the cavum-near decidual layer at the uterotomy margin.

Participants will be followed 6 to 9 months after cesarean delivery, including blinded ultrasound assessment of cesarean scar healing. The objective is to determine whether decidual inclusion or decidual sparing is associated with differences in postoperative uterine scar healing and cesarean scar defect formation.

Enrollment: 374 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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374 participants in 2 patient groups

Decidual Inclusion Closure

Experimental group

Description:

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.

Treatment:

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

Decidual Sparing Closure

Experimental group

Description:

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.

Treatment:

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