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Comparing Cesarean Scar Defect Incidence After Locked and Unlocked Repair Methods Among Primiparous Patients

Comparing Cesarean Scar Defect Incidence After Locked and Unlocked Repair Methods Among Primiparous Patients: A Randomized Double-blinded Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231028059887N1
Enrollment
60
Registered
2024-01-17
Start date
2021-03-10
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean scar defect.

Interventions

Intervention 1: First intervention group: Two-layer locked uterine closure following the cesarean section. Intervention 2: Second intervention group: Two-layer unlocked uterine closure following the c

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Primiparous term pregnant women in their third trimester Eligible for primary cesarean section Possessing a normal pre-pregnancy body mass index (BMI) Lacking pre-pregnancy medical conditions Free from major pregnancy complications like gestational hypertension, preeclampsia, eclampsia, and gestational diabetes mellitus Not in the latent phase of labor Presenting with a fetal head station of zero or higher (-3, -2, -1, and 0) No history of prior lower uterine segment surgery

Exclusion criteria

Exclusion criteria: Extension of the cesarean section incision during the procedure Pregnancy during the one-year follow-up period Patient unwillingness Patient non-cooperation

Design outcomes

Primary

MeasureTime frame
Residual myometrial thickness. Timepoint: one year following the cesarean section. Method of measurement: ultrasonographic examination by an experienced obstetrics and gynecologist specialist.;Scar depth. Timepoint: one year following the cesarean section. Method of measurement: ultrasonographic examination by an experienced obstetrics and gynecologist specialist.;Scar width. Timepoint: one year following the cesarean section. Method of measurement: ultrasonographic examination by an experienced obstetrics and gynecologist specialist.;Presence/absence of cesarean scar defect (defined as scar depth larger than 2 millimeters). Timepoint: one year following the cesarean section. Method of measurement: ultrasonographic examination by an experienced obstetrics and gynecologist specialist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAzadeh Tarafdari Manshadi

Tehran University of Medical Sciences

azadehmehr@gmail.com0098 21 61190

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026