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Single or Double-layer Uterine Closure Techniques

NCT03629028 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2020-05-01

Study results available
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Summary

There are different surgical techniques of uterine closure during cesarean. A growing data has suggested that the closure technique has an effect on uterine scar healing. Residual myometrium thickness and uterine scar defect (niche) development seems to be related to the single or double layer closure of uterus. In that study, investigators will search for the effect of single or double layer closure of uterus during cesarean on the uterine scar defect.

Conditions

  • Uterine Scar
  • Cesarean Section Complications
  • Cesarean Section; Dehiscence

Interventions

DIAGNOSTIC_TEST

Residual myometrium thickness

The myometrium will be closed by single or double layer during cesarean and residual myometrium thickness will be evaluated in 6 to 9 months by saline infusion sonography.

DIAGNOSTIC_TEST

Niche Presence

The myometrium will be closed by single or double layer during cesarean and niche presence will be evaluated in 6 to 9 months by saline infusion sonography.

DIAGNOSTIC_TEST

Adjacent myometrium thickness

The myometrium will be closed by single or double layer during cesarean and adjacent myometrium thickness will be evaluated in 6 to 9 months by saline infusion sonography.

DIAGNOSTIC_TEST

Niche Measurements (depth of niche, width of niche, length of niche)

The myometrium will be closed by single or double layer during cesarean and three dimensional niche measurements will be evaluated in 6 to 9 months by saline infusion sonography.

Sponsors & Collaborators

  • Safak Baran Yilmaz

    lead OTHER

Principal Investigators

  • Şafak YILMAZ BARAN, M.D. · Baskent University Department of Obstetrics and Gynecology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-18
Primary Completion
2018-08-18
Completion
2020-03-10

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03629028 on ClinicalTrials.gov