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Refined Three-Layer Versus Conventional Two-Layer Uterine Closure for Early Cesarean Scar Morphology: A Randomized Controlled Trial

Refined Three-Layer Versus Conventional Two-Layer Uterine Closure for Early Cesarean Scar Morphology: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260629004
Enrollment
60
Registered
2026-06-29
Start date
2025-12-16
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Cesarean scar morphology following primary cesarean delivery Cesarean section, uterine closure, cesarean scar, uterine niche, residual myometrial thickness, transvaginal ultrasonography, randomized controlled trial

Interventions

The uterine incision was closed using a refined three-layer technique. The first layer approximated the decidual-myometrial junction while excluding the endometrial surface using a continuous non-lock
Experimental Procedure/Surgery,Active Comparator Procedure/Surgery
Refined three-layer uterine closure,Conventional two-layer uterine closure

Sponsors

No
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Singleton pregnancy, 2. Gestational age of 37 weeks or more, 3. Undergoing primary cesarean delivery through a low transverse uterine incision, 4. Ability to provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Previous cesarean delivery or other uterine surgery, 2. Known uterine anomaly, 3. Placenta previa, 4. Placenta accreta spectrum, 5. Intraoperative condition requiring modification of the allocated uterine closure technique

Design outcomes

Primary

MeasureTime frame
Residual to adjacent myometrial thickness ratio 6 weeks postpartum Ratio calculated by dividing residual myometrial thickness by adjacent myometrial thickness, measured by transvaginal ultrasound in the midsagittal plane

Secondary

MeasureTime frame
Residual myometrial thickness 6 weeks postpartum Thickness in millimeters measured from the deepest point of the scar indentation to the uterine serosal surface by transvaginal ultrasound in the midsagittal plane,Adjacent myometrial thickness 6 weeks postpartum Thickness in millimeters measured in the myometrium adjacent to the cesarean scar by transvaginal ultrasound in the midsagittal plane,Niche depth 6 weeks postpartum Vertical depth in millimeters from the endometrial surface to the deepest point of the scar indentation by transvaginal ultrasound,Niche width 6 weeks postpartum Maximum width in millimeters of the scar indentation measured in the midsagittal plane by transvaginal ultrasound,Niche depth to adjacent myometrial thickness ratio 6 weeks postpartum Ratio calculated by dividing niche depth by adjacent myometrial thickness measured by transvaginal ultrasound,Presence of cesarean scar niche 6 weeks postpartum Presence or absence of a scar indentation with a depth of at least 2 mm on transvaginal ultrasound,Operative time During cesarean delivery Time in minutes from skin incision to completion of skin closure,Estimated blood loss During cesarean delivery Estimated intraoperative blood loss in milliliters

Countries

Thailand

Contacts

Public ContactAngkharn Triniti

Surin Hospital

angkharn.noom@gmail.com0918287237

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026