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.
Singleton, term pregnancy
Elective cesarean section before labor onset or membrane rupture
Maternal age >18 years
Ability to provide informed consent
Placenta previa
Maternal substance abuse or infection
Suspected placenta accreta
Diabetes
Parallel
Single-Layered Non-Locked Closure with Decidual Inclusion
Procedure/SurgeryDuring 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/SurgeryProcedure: 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.
Operative time
Operative time in minutes
Need for additional sutures for hemostasis
Need for additional hemostatic sutures, yes (how many: \_\_ Number) /no
Length of hospital stay
Length of postoperative hospital stay in days
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.
Click on the lead sponsor to view all of their trials.