Cesarean Scar Diverticula, Isthmocele
Conditions
Keywords
isthmocele, Uterine closure techniques, Decidual inclusion, Decidual sparing, Cesarean section, Scar thickness, Niche formation, Sonography, Dyspareunia
Brief summary
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
PROCEDURESingle-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.
PROCEDURESingle-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.
Sponsors
Kantonsspital Baden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with a cesarean scar niche measured by ultrasound | 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
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Periprocedural | Operative time in minutes |
| Need for additional sutures for hemostasis | Periprocedural | Need for additional hemostatic sutures, yes (how many: \_\_ Number) /no |
| Length of hospital stay | Postoperative day 2 | Length of postoperative hospital stay in days |
| Postoperative pain intensity on the 11-point Numeric Rating Scale | 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. |
| Postoperative bleeding | Postoperative day 2 | Clinically relevant postoperative bleeding, yes/no |
| Wound infection | Postoperative day 2 | Postoperative wound infection, yes/no |
| Postoperative fever | Postoperative day 2 | Postoperative fever, yes/no |
| Abnormal uterine bleeding | 6 to 9 months post-operation | Abnormal uterine bleeding reported at follow-up, yes/no |
| Dysmenorrhea | 6 to 9 months post-operation | Dysmenorrhea reported at follow-up, yes/no |
| Chronic pelvic pain | 6 to 9 months post-operation | Chronic pelvic pain reported at follow-up, yes/no |
| Dyspareunia | 6 to 9 months post-operation | Dyspareunia reported at follow-up, yes/no |
| Cesarean scar niche length measured by ultrasound in mm | 6 to 9 months post-operation | Length of cesarean scar niche in mm measured by ultrasound. |
| Cesarean scar niche depth measured by ultrasound in mm | 6 to 9 months post-operation | Depth of cesarean scar niche in mm measured by ultrasound. |
| Cesarean scar niche width measured by ultrasound in mm | 6 to 9 months post-operation | Width of cesarean scar niche in mm measured by ultrasound. |
| Residual myometrial thickness measured by ultrasound in mm | 6 to 9 months post-operation | Residual myometrial thickness measured by ultrasound in mm |
| Presence of intrauterine fluid on ultrasound | 6 to 9 months post-operation | Presence or absence of intrauterine fluid on ultrasound. |
| Residual-to-adjacent myometrial thickness ratio | 6 to 9 months post-operation | Ratio of residual myometrial thickness to adjacent myometrial thickness measured by ultrasound. |
Countries
Switzerland
Contacts
CONTACTAmr S. Hamza, Assoc. Prof.
CONTACTLeonhard Schaeffer, Prof.
PRINCIPAL_INVESTIGATORAmr S. Hamza, Assoc. Prof.
Kantonsspital Baden
Outcome results
None listed