An interventional study of Primary Cesarean Section and immediate postplacental insertion of a copper T380A intrauterine device in Scar Niche, Myometrial Remodeling and Contraceptive Device; Complications, sponsored by Benha University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Benha University · Not applicable, Interventional, and Diagnostic
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 .
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.
Benha University is the lead sponsor of 356 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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 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 .
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
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 .
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
Time frame: at 3 and 6 months postpartum
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: At 6 months postpartum
Plan to share: No
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Benha University