An interventional study of Single-Layered Non-Locked Closure with Decidual Inclusion and Single-Layered Non-Locked Closure with Decidual Sparing in Isthmocele and Cesarean Scar Diverticula, sponsored by Kantonsspital Baden. Recruiting at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Kantonsspital Baden · Not applicable, Interventional, and Prevention
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.
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.
158 studies on the registry are indexed under Dyspareunia; 40 are open to participants now.
This study's planned enrollment of 374 is above the median of 63 across 126 interventional studies indexed under Dyspareunia.
Browse Dyspareunia studies →Kantonsspital Baden is the lead sponsor of 15 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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: 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.
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.
Time frame: 6 to 9 months post-operation
Operative time
Operative time in minutes
Time frame: Periprocedural
Need for additional sutures for hemostasis
Need for additional hemostatic sutures, yes (how many: \_\_ Number) /no
Time frame: Periprocedural
Length of hospital stay
Length of postoperative hospital stay in days
Time frame: Postoperative day 2
Postoperative pain intensity on the 11-point Numeric Rating Scale
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.
Time frame: Postoperative day 2
Postoperative bleeding
Clinically relevant postoperative bleeding, yes/no
Time frame: Postoperative day 2
Wound infection
Postoperative wound infection, yes/no
Time frame: Postoperative day 2
Postoperative fever
Postoperative fever, yes/no
Time frame: Postoperative day 2
Abnormal uterine bleeding
Abnormal uterine bleeding reported at follow-up, yes/no
Time frame: 6 to 9 months post-operation
Dysmenorrhea
Dysmenorrhea reported at follow-up, yes/no
Time frame: 6 to 9 months post-operation
Chronic pelvic pain
Chronic pelvic pain reported at follow-up, yes/no
Time frame: 6 to 9 months post-operation
Dyspareunia
Dyspareunia reported at follow-up, yes/no
Time frame: 6 to 9 months post-operation
Cesarean scar niche length measured by ultrasound in mm
Length of cesarean scar niche in mm measured by ultrasound.
Time frame: 6 to 9 months post-operation
Cesarean scar niche depth measured by ultrasound in mm
Depth of cesarean scar niche in mm measured by ultrasound.
Time frame: 6 to 9 months post-operation
Cesarean scar niche width measured by ultrasound in mm
Width of cesarean scar niche in mm measured by ultrasound.
Time frame: 6 to 9 months post-operation
Residual myometrial thickness measured by ultrasound in mm
Residual myometrial thickness measured by ultrasound in mm
Time frame: 6 to 9 months post-operation
Presence of intrauterine fluid on ultrasound
Presence or absence of intrauterine fluid on ultrasound.
Time frame: 6 to 9 months post-operation
Residual-to-adjacent myometrial thickness ratio
Ratio of residual myometrial thickness to adjacent myometrial thickness measured by ultrasound.
Time frame: 6 to 9 months post-operation
Plan to share: No — De-identified individual participant data will not be shared outside the research team because no external data-sharing process has been approved by the ethics committee or institution. Aggregate study results may be shared through publication or presentation.
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for May 2029, 34 months after the start.
Of 51 non-industry interventional studies with no phase under Dyspareunia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 48. This study's planned 34 months is close to that.
Counting every sponsor, half of 59 studies reached it within 33 months; a quarter within 13 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
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