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

NCT07264933 | Completed

• 1 other identifier: RC12-2-2025
• Study Type: interventional
• Target: 750
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

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

Keywords

Primary cesarean section; intrauterine device; post placental copper T380A; uterine niche; residual myometrial thickness; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Rate of uterine niche formation after primary cesarean section.

  using transvaginal ultrasound (2D, sagittal and coronal views), a niche is defined as an indentation ≥2 mm in the myometrium at the previous cesarean scar site

  at 3 and 6 months postpartum

Secondary Outcomes (4)

• Rate of intrauterine device displacement

  At 3 and 6 months postpartum

• Uterine niche measurements.

  At 6 months postpartum

• Menstrual bleeding outcomes in participants with uterine niche.

  At 6 months postpartum

• Breastfeeding outcomes.

  At 6 months postpartum

Study Arms (2)

Immediate postplacental copper T380A intrauterine device

ACTIVE COMPARATOR

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

Procedure: Primary Cesarean Section; Device: immediate postplacental insertion of a copper T380A intrauterine device; Diagnostic Test: Transvaginal ultrasound

Postpartum progesterone-only pills

ACTIVE COMPARATOR

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.

Procedure: Primary Cesarean Section; Drug: progesterone-only pills; Diagnostic Test: Transvaginal ultrasound

Interventions

Primary Cesarean Section PROCEDURE

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.

Immediate postplacental copper T380A intrauterine device; Postpartum progesterone-only pills

progesterone-only pills DRUG

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.

Also known as: Microlut®; Bayer

Postpartum progesterone-only pills

Transvaginal ultrasound DIAGNOSTIC_TEST

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 .

Immediate postplacental copper T380A intrauterine device; Postpartum progesterone-only pills

immediate postplacental insertion of a copper T380A intrauterine device 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 .

Immediate postplacental copper T380A intrauterine device

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha Univesity Hospital

Banhā, Qalyubia Governorate, 13512, Egypt

Location

Related Publications (8)

• Committee on Practice Bulletins-Gynecology, Long-Acting Reversible Contraception Work Group. Practice Bulletin No. 186: Long-Acting Reversible Contraception: Implants and Intrauterine Devices. Obstet Gynecol. 2017 Nov;130(5):e251-e269. doi: 10.1097/AOG.0000000000002400.

  PMID: 29064972 BACKGROUND

• Wu M, Eisenberg R, Negassa A, Levi E. Associations between immediate postpartum long-acting reversible contraception and short interpregnancy intervals. Contraception. 2020 Dec;102(6):409-413. doi: 10.1016/j.contraception.2020.08.016. Epub 2020 Sep 10.

  PMID: 32918870 BACKGROUND

• Jordans IPM, de Leeuw RA, Stegwee SI, Amso NN, Barri-Soldevila PN, van den Bosch T, Bourne T, Brolmann HAM, Donnez O, Dueholm M, Hehenkamp WJK, Jastrow N, Jurkovic D, Mashiach R, Naji O, Streuli I, Timmerman D, van der Voet LF, Huirne JAF. Sonographic examination of uterine niche in non-pregnant women: a modified Delphi procedure. Ultrasound Obstet Gynecol. 2019 Jan;53(1):107-115. doi: 10.1002/uog.19049.

  PMID: 29536581 BACKGROUND

• Klein Meuleman SJM, Min N, Hehenkamp WJK, Post Uiterweer ED, Huirne JAF, de Leeuw RA. The definition, diagnosis, and symptoms of the uterine niche - A systematic review. Best Pract Res Clin Obstet Gynaecol. 2023 Aug;90:102390. doi: 10.1016/j.bpobgyn.2023.102390. Epub 2023 Jul 15.

  PMID: 37506497 BACKGROUND

• Doulaveris G, Jou J, Leung WK, Bircaj E, Orfanelli T, Atrio J, Dar P, Rotenberg O. Association of Intrauterine Device Malposition With Previous Cesarean Delivery and Related Uterine Anatomical Changes. J Ultrasound Med. 2024 Jun;43(6):1121-1129. doi: 10.1002/jum.16440. Epub 2024 Feb 29.

  PMID: 38421056 BACKGROUND

• Seleem M, Sedik MM, Megahed AMM, Nabil H. Conventional manual technique of post placental IUD insertion versus intra-cesarean post placental introducer withdrawal IUD insertion technique: a new standardized technique for IUD insertion during cesarean section: a randomized controlled trial. BMC Pregnancy Childbirth. 2023 Jun 26;23(1):474. doi: 10.1186/s12884-023-05777-1.

  PMID: 37365489 RESULT

• Osser OV, Jokubkiene L, Valentin L. Cesarean section scar defects: agreement between transvaginal sonographic findings with and without saline contrast enhancement. Ultrasound Obstet Gynecol. 2010 Jan;35(1):75-83. doi: 10.1002/uog.7496.

  PMID: 20034000 RESULT

• Levi EE, Stuart GS, Zerden ML, Garrett JM, Bryant AG. Intrauterine Device Placement During Cesarean Delivery and Continued Use 6 Months Postpartum: A Randomized Controlled Trial. Obstet Gynecol. 2015 Jul;126(1):5-11. doi: 10.1097/AOG.0000000000000882.

  PMID: 26241250 RESULT

MeSH Terms

Interventions

Levonorgestrel

Intervention Hierarchy (Ancestors)

Norgestrel; Norpregnenes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• AHMED ALNEZAMY, MD

  Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology, Faculty of Medicine

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: February 12, 2025
• Primary Completion: August 5, 2025
• Study Completion: February 5, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)