Postplacental Copper Intrauterine Device Versus Postpartum Progesterone-only Pills on Uterine Niche Formation (T380A)

Benha University

Status: Active, not recruiting

Conditions: Cesarean Section Complications; Contraceptive Device; Complications; Scar Niche; Myometrial Remodeling

Treatments: Procedure: Primary Cesarean Section; Drug: progesterone-only pills; Device: immediate postplacental insertion of a copper T380A intrauterine device; Diagnostic Test: Transvaginal ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT07264933

RC12-2-2025

Details and patient eligibility

About

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 .

Full 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 .

Enrollment: 750 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• primigravida with a gestational age of ≥37 weeks
• express a desire for postpartum contraception.
• acceptance to participate and to provide written informed consent
• willing to attend follow-up for 6 months postpartum.

Exclusion criteria

• Known uterine anomalies
• Chorioamnionitis
• Premature rupture of membranes > 24 hours
• Previous uterine surgery
• Cervical dysplasia
• Uterine fibroids
• Multiple gestation
• Placenta previa or placental abruption
• Preeclampsia or eclampsia
• Hemoglobin < 10 g/dL
• Any uncontrolled systemic disease
• Current tobacco use
• Chronic corticosteroid therapy
• Inability to provide informed consent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 2 patient groups

Immediate postplacental copper T380A intrauterine device

Active Comparator group

Description:

In the Study group, immediate postplacental insertion of a copper T380A intrauterine device was performed intraoperatively using the standardized intracesarean introducer-withdrawal technique.

Treatment:

Diagnostic Test: Transvaginal ultrasound

Device: immediate postplacental insertion of a copper T380A intrauterine device

Procedure: Primary Cesarean Section

Postpartum progesterone-only pills

Active Comparator group

Description:

In the control group, participants did not receive an intraoperative intrauterine device . They were instructed to initiate daily oral intake of progesterone-only pills at 4 weeks postpartum and at least 5 days before resuming sexual activity and to continue using it till at least the end of the sixth month postpartum.

Treatment:

Diagnostic Test: Transvaginal ultrasound

Drug: progesterone-only pills

Procedure: Primary Cesarean Section