drugset / Trial / NCT07264933
Postplacental Copper Intrauterine Device Versus Postpartum Progesterone-only Pills on Uterine Niche Formation
RandomizedParallel-groupOpen-labelDiagnostic
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 .
Timeline
- Start
- 2025-02-12
- Primary completion
- 2025-08-05
- Completion
- 2026-02-05
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- Results 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.
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Levonorgestrel | Small molecule | 0.03 mg | Oral |