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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Operative time in minutes | Periprocedural |
| Need for additional sutures for hemostasis | Need for additional hemostatic sutures, yes (how many: __ Number) /no |
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Inclusion Criteria:
Exclusion Criteria:
Female pregnant women who are receiving a cesarean section.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amr S. Hamza, Assoc. Prof. | Contact | +41564863513 | amr.hamza@ksb.ch | |
| Leonhard Schaeffer, Prof. | Contact | +41564863506 | leonhard.schaeffer@ksb.ch |
| Name | Affiliation | Role |
|---|---|---|
| Amr S. Hamza, Assoc. Prof. | Kantonsspital Baden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kantonsspital Baden | Baden | Canton of Aargau | 5400 | Switzerland |
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.
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| 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. |
|
| Periprocedural |
| Length of hospital stay | Length of postoperative hospital stay in days | 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. | Postoperative day 2 |
| Postoperative bleeding | Clinically relevant postoperative bleeding, yes/no | Postoperative day 2 |
| Wound infection | Postoperative wound infection, yes/no | Postoperative day 2 |
| Postoperative fever | Postoperative fever, yes/no | Postoperative day 2 |
| Abnormal uterine bleeding | Abnormal uterine bleeding reported at follow-up, yes/no | 6 to 9 months post-operation |
| Dysmenorrhea | Dysmenorrhea reported at follow-up, yes/no | 6 to 9 months post-operation |
| Chronic pelvic pain | Chronic pelvic pain reported at follow-up, yes/no | 6 to 9 months post-operation |
| Dyspareunia | Dyspareunia reported at follow-up, yes/no | 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. | 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. | 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. | 6 to 9 months post-operation |
| Residual myometrial thickness measured by ultrasound in mm | Residual myometrial thickness measured by ultrasound in mm | 6 to 9 months post-operation |
| Presence of intrauterine fluid on ultrasound | Presence or absence of intrauterine fluid on ultrasound. | 6 to 9 months post-operation |
| Residual-to-adjacent myometrial thickness ratio | Ratio of residual myometrial thickness to adjacent myometrial thickness measured by ultrasound. | 6 to 9 months post-operation |
| ID | Term |
|---|---|
| D004414 | Dyspareunia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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