CompletedNot Applicable

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

Egypt750 participantsStarted 2025-02-12

Plain-language 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 .

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rate of uterine niche formation after primary cesarean section.

Timeframe: at 3 and 6 months postpartum

Trial details

NCT IDNCT07264933

SponsorBenha University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-05

View on ClinicalTrials.gov More Scar Niche trials