NCT07264933

Postplacental Copper Intrauterine Device Versus Postpartum Progesterone-only Pills on Uterine Niche Formation

Effect of Immediate Postplacental Copper T380A Intrauterine Device Insertion Versus Postpartum Progesterone-only Pills on Uterine Niche Formation After Primary Cesarean Section: a Prospective, Open-label Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 750 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether immediate postplacental copper T380A intrauterine device insertion increases uterine-niche incidence compared with postpartum progestin-only pills after primary cesarean section .

Detailed description

Eligible primigravida participants aged 18-45 years with a gestational age of ≥37 weeks undergoing a primary cesarean section for any indication were required to provide written informed consent, agree to attend follow-up visits for 6 months postpartum, and express a desire for postpartum contraception. After confirming eligibility and obtaining consent, a trained nurse selected an envelope for each patient and revealed the allocation to the patient and the operating obstetrician. Participants were randomized1:1 to either immediate postplacental insertion of copper T380A intrauterine device performed intraoperatively using the standardized intracesarean introducer-withdrawal technique or not to receive an intraoperative intrauterine device but they were instructed to initiate progesterone-only pills 4 weeks postpartum and at least 5 days before resuming sexual activity, till at least the end of 6th month postpartum. All lower-segment cesarean sections were performed by qualified obstetricians at Benha University Hospitals who were trained on the study protocol. The standard Kerr technique was used for the uterine incision, followed by double-layer continuous myometrial closure with braided polyglycolic acid 0-1 sutures, ensuring decidual sparing and visceral peritoneum closure. Follow-up visits were scheduled at 3 and 6 months postpartum. * Ultrasound Assessment: Two independent, trained sonographers-blinded to each other's findings-perform transvaginal ultrasound examinations in both sagittal and coronal planes. At 3 and 6 months postpartum,intrauterine device displacement is considered if the distance between the dome of the uterine cavity to the upper part of the intrauterine device is \> 3 mm and these participants will be provided with another method of contraception according to their wish and will be excluded from the final analysis . At 3 and 6 months postpartum, a niche is defined as an indentation ≥2 mm in the myometrium at the previous cesarean scar site. At 6 months postpartum uterine niche depth, length, width and residual myometrial thickness are to be recorded . * Clinical Assessment: A separate obstetrician/gynecologist will collect data on menstrual patterns and breastfeeding initiation and continuation .

Conditions

• Scar Niche
• Myometrial Remodeling
• Contraceptive Device; Complications
• Cesarean Section Complications

Interventions

Type	Name	Description
PROCEDURE	Primary Cesarean Section	All lower-segment cesarean sections were performed by qualified obstetricians at Benha University Hospitals who were trained on the study protocol. The standard Kerr technique was used for the uterine incision, followed by double-layer continuous myometrial closure with braided polyglycolic acid 0-1 sutures, with decidual sparing and visceral peritoneal closure.
DEVICE	immediate postplacental insertion of a copper T380A intrauterine device	immediate postplacental insertion of a copper T380A intrauterine device was performed intraoperatively using the standardized intracesarean introducer-withdrawal technique. The intrauterine device introducer with the intrauterine device threads inside is trimmed to 12 cm. The uterus is held and stabilized with the non-dominant hand, and the introducer is inserted first downwards through the cervical canal before pushing it up to put it firmly against the endometrium of the uterine fundus. Then, it is pulled gently down through the cervical canal to the vagina while pressing on the fundus with the non-dominant hand, thus ensuring that the intrauterine device is kept at the fundus and that the intrauterine device threads are in the cervical canal. the introducer is removed gently manually from the vagina at the end of the cesarean section after closure of the skin and ceiling of the wound .
DRUG	progesterone-only pills	Participants were instructed to initiate daily oral intake of progesterone-only pills containing 0.03 mg levonorgestrel per pill (Microlut®; Bayer) at 4 weeks postpartum and at least 5 days before resuming sexual activity. The participants were asked to use it continuously at least till the end of the 6th month postpartum. This product is commercially available in Egypt and contains 35 active tablets per pack.
DIAGNOSTIC_TEST	Transvaginal ultrasound	Two independent, trained sonographers-blinded to each other's findings- will perform transvaginal ultrasound examinations in both sagittal and coronal planes. At 3 and 6 months postpartum,intrauterine device displacement is considered if the distance between the dome of the uterine cavity to the upper part of the intrauterine device is \> 3 mm and these participants will be excluded from the final analysis . At 3 and 6 months postpartum, a niche is defined as an indentation ≥2 mm in the myometrium at the previous cesarean scar site. At 6 months postpartum uterine niche depth, length, width and residual myometrial thickness are to be recorded .

Timeline

• Start date: 2025-02-12
• Primary completion: 2025-08-05
• Completion: 2026-02-05
• First posted: 2025-12-04
• Last updated: 2026-02-27

Locations

1 site across 1 country: Egypt