Ignite Creation Date:
2025-12-25 @ 12:20 AM
Ignite Modification Date:
2025-12-25 @ 10:23 PM
Study NCT ID:
NCT07228858
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Uterine Scar Resection During Repeat Cesarean Delivery to Prevent Uterine Niche Formation
Sponsor:
Benha University
Organization:
Study Overview
Official Title:
Uterine Scar Resection During Repeat Cesarean Delivery in a Simple Modification to Prevent Uterine Niche Formation: Results of a Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to evaluate whether resection of the previous cesarean scar at repeat cesarean delivery reduces uterine niche formation and related morbidity without increasing operative risks.
Detailed Description:
After eligibility and consenting, multigravida women with ≥1 prior cesarean section scheduled for repeat cesarean section at ≥28 weeks' gestation for any indication were randomized to
* Study group: During repeat cesarean section, the prior uterine scar was resected. After creating the bladder flap, the uterus was incised 5 mm cranial to the scar and extended laterally 5 mm beyond its ends. Following delivery, a 1 cm segment of uterine wall (5 mm above and below the scar) was excised. The incision edges were approximated with a central vertical mattress suture, followed by double-layer continuous myometrial closure (including decidua) and visceral peritoneum closure.
* Control group: Standard repeat cesarean section without scar resection, followed by identical double-layer and peritoneal closure.
All procedures were performed by obstetricians trained in the protocol. All women received standard preoperative antibiotics, 24-hour postoperative prophylaxis, and 10 units intramuscular oxytocin after delivery.
At 6 months postpartum, all participants will undergo transvaginal ultrasound and saline infusion sonohysterography performed by a blinded, experienced examiner. Sagittal and coronal views willl be obtained, and niche presence, depth, length, width, and residual myometrial thickness are to be recorded.
Obstetricians were informed of assignment, while participants and ultrasound assessor are blinded.
* Study group: During repeat cesarean section, the prior uterine scar was resected. After creating the bladder flap, the uterus was incised 5 mm cranial to the scar and extended laterally 5 mm beyond its ends. Following delivery, a 1 cm segment of uterine wall (5 mm above and below the scar) was excised. The incision edges were approximated with a central vertical mattress suture, followed by double-layer continuous myometrial closure (including decidua) and visceral peritoneum closure.
* Control group: Standard repeat cesarean section without scar resection, followed by identical double-layer and peritoneal closure.
All procedures were performed by obstetricians trained in the protocol. All women received standard preoperative antibiotics, 24-hour postoperative prophylaxis, and 10 units intramuscular oxytocin after delivery.
At 6 months postpartum, all participants will undergo transvaginal ultrasound and saline infusion sonohysterography performed by a blinded, experienced examiner. Sagittal and coronal views willl be obtained, and niche presence, depth, length, width, and residual myometrial thickness are to be recorded.
Obstetricians were informed of assignment, while participants and ultrasound assessor are blinded.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: