Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single-Layered Non-Locked Closure with Decidual Inclusion, Single-Layered Non-Locked Closure with Decidual Sparing.
- Who it may be relevant to
- Registry conditions: Isthmocele, Cesarean Scar Diverticula. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of Decidual Inclusion or Sparing in a Single Unlocked Closure of a Cesarean Uterine Incision: Randomized Controlled Trial
Overview
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.
Detailed 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.
Interventions
- Procedure Single-Layered Non-Locked Closure with Decidual Inclusion
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. - Procedure Single-Layered Non-Locked Closure with Decidual Sparing
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.
Primary outcome measures
- Proportion of participants with a cesarean scar niche measured by ultrasound [Time frame: 6 to 9 months post-operation]
Secondary outcome measures (12)
- Operative time [Time frame: Periprocedural]
- Need for additional sutures for hemostasis [Time frame: Periprocedural]
- Length of hospital stay [Time frame: Postoperative day 2]
- Postoperative pain intensity on the 11-point Numeric Rating Scale [Time frame: Postoperative day 2]
- Postoperative bleeding [Time frame: Postoperative day 2]
- Wound infection [Time frame: Postoperative day 2]
- Postoperative fever [Time frame: Postoperative day 2]
- Abnormal uterine bleeding [Time frame: 6 to 9 months post-operation]
- Dysmenorrhea [Time frame: 6 to 9 months post-operation]
- Chronic pelvic pain [Time frame: 6 to 9 months post-operation]
- Dyspareunia [Time frame: 6 to 9 months post-operation]
- Cesarean scar niche length measured by ultrasound in mm [Time frame: 6 to 9 months post-operation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
Switzerland · 1 center
- Kantonsspital Baden — Baden
Identifiers
NCT: NCT07608874 · StudyKSBHAM001