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

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

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 .

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Contraceptive Device; Complications; Myometrial Remodeling; Scar Niche
• Intervention / Treatment: Procedure: Primary Cesarean Section; Diagnostic test: Transvaginal ultrasound; Drug: progesterone-only pills; Device: immediate postplacental insertion of a copper T380A intrauterine device

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 .

• Study Type: Interventional
• Enrollment (Actual): 750
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Qalyubia Governorate
    • Banhā, Qalyubia Governorate, Egypt, 13512
      • Benha Univesity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Postpartum progesterone-only pills; 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; 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.; 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 .; 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.; Other Names: Microlut®; Bayer
Active Comparator: Immediate postplacental copper T380A intrauterine device; 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; 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.; 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 .; 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of intrauterine device displacement	Among the immediate postplacental copper T380A intrauterine device insertion group of participants, ,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 on transvaginal ultrasound examination.	At 3 and 6 months postpartum
Uterine niche measurements.	In participants with niche diagnosed using transvaginal ultrasound (2D, sagittal and coronal views), uterine niche depth, length, width and residual myometrial thickness are to be recorded.	At 6 months postpartum
Menstrual bleeding outcomes in participants with uterine niche.	A separate obstetrician/gynecologist will collect data on menstrual patterns in participants with uterine niche in both groups including amenorrhea, postmenstrual / intermenstrual spotting and total bleeding days per cycle	At 6 months postpartum
Breastfeeding outcomes.	A separate obstetrician/gynecologist will collect data on breastfeeding outcomes in both groups including initiation and continuation of breast feeding.	At 6 months postpartum

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: AHMED ALNEZAMY, MD, Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Benha University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2025
• Primary Completion (Actual): August 5, 2025
• Study Completion (Actual): February 5, 2026

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: November 24, 2025
• First Posted (Actual): December 4, 2025

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 25, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; intrauterine device; Primary cesarean section; post placental copper T380A; uterine niche; residual myometrial thickness
• Additional Relevant MeSH Terms: Polycyclic Compounds; Steroids; Fused-Ring Compounds; Norpregnenes; Norpregnanes; Norsteroids; Norgestrel; Levonorgestrel
• Other Study ID Numbers: RC12-2-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No