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NCT Number: NCT07608874

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

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.

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Key information

Conditions

Isthmocele Cesarean Scar Diverticula Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Proportion of participants with a cesarean scar niche measured by ultrasound

    Time frame: 6 to 9 months post-operation

    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.

Secondary outcomes

  1. Operative time

    Time frame: Periprocedural

    Operative time in minutes

  2. Need for additional sutures for hemostasis

    Time frame: Periprocedural

    Need for additional hemostatic sutures, yes (how many: __ Number) /no

  3. Length of hospital stay

    Time frame: Postoperative day 2

    Length of postoperative hospital stay in days

  4. Postoperative pain intensity on the 11-point Numeric Rating Scale

    Time frame: Postoperative day 2

    Pain intensity assessed using an 11-point Numeric Rating Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain.

  5. Postoperative bleeding

    Time frame: Postoperative day 2

    Clinically relevant postoperative bleeding, yes/no

  6. Wound infection

    Time frame: Postoperative day 2

    Postoperative wound infection, yes/no

  7. Postoperative fever

    Time frame: Postoperative day 2

    Postoperative fever, yes/no

  8. Abnormal uterine bleeding

    Time frame: 6 to 9 months post-operation

    Abnormal uterine bleeding reported at follow-up, yes/no

  9. Dysmenorrhea

    Time frame: 6 to 9 months post-operation

    Dysmenorrhea reported at follow-up, yes/no

  10. Chronic pelvic pain

    Time frame: 6 to 9 months post-operation

    Chronic pelvic pain reported at follow-up, yes/no

  11. Dyspareunia

    Time frame: 6 to 9 months post-operation

    Dyspareunia reported at follow-up, yes/no

  12. Cesarean scar niche length measured by ultrasound in mm

    Time frame: 6 to 9 months post-operation

    Length of cesarean scar niche in mm measured by ultrasound.

  13. Cesarean scar niche depth measured by ultrasound in mm

    Time frame: 6 to 9 months post-operation

    Depth of cesarean scar niche in mm measured by ultrasound.

  14. Cesarean scar niche width measured by ultrasound in mm

    Time frame: 6 to 9 months post-operation

    Width of cesarean scar niche in mm measured by ultrasound.

  15. Residual myometrial thickness measured by ultrasound in mm

    Time frame: 6 to 9 months post-operation

    Residual myometrial thickness measured by ultrasound in mm

  16. Presence of intrauterine fluid on ultrasound

    Time frame: 6 to 9 months post-operation

    Presence or absence of intrauterine fluid on ultrasound.

  17. Residual-to-adjacent myometrial thickness ratio

    Time frame: 6 to 9 months post-operation

    Ratio of residual myometrial thickness to adjacent myometrial thickness measured by ultrasound.

Study contacts

Contact information is provided by the study sponsor or research team.

Amr S. Hamza, Assoc. Prof.

CONTACT

[email protected]

+41564863513

Leonhard Schaeffer, Prof.

CONTACT

[email protected]

+41564863506

Sponsors and collaborators

Lead sponsor

Kantonsspital Baden

Other

Registry information

Official study title

The Impact of Decidual Inclusion or Sparing in a Single Unlocked Closure of a Cesarean Uterine Incision: Randomized Controlled Trial

Acronym: DISSUC

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 27, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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