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Clinical Trials/NCT03915847
NCT03915847CompletedNot Applicable

Evaluation of Cesarean Scar After Three Different Uterine Closure Technis: A Randomised Trial

Ataturk University1 site in 1 country90 target enrollmentStarted: April 16, 2019Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
90
Locations
1
Primary Endpoint
Residual myometrial thickness
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The study compares three techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. Cesarean scar will be evaluated by transvaginal ultrasound six months after cesarean.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Previous two or three cesarean
  • •Gestational weeks >=36 weeks

Exclusion Criteria

  • •Risk of obstetric haemorrhage
  • •Suspicion or diagnosis placenta previa or accrete syndrome
  • •Chorioamnionitis
  • •Uterine myoma in the anterior uterine segment
  • •Hysterotomy other than lower segment uterine incision at previous cesarean

Outcomes

Primary Outcomes

Residual myometrial thickness

Time Frame: 6 months after cesarean

Myometrial thickness at the uterine scar by transvaginal ultrasound

Secondary Outcomes

  • Length of hospitalization(One month after cesarean)
  • Depth of defect (niche)(6 months after cesarean)
  • Operation time(10 minute after cesarean completed)
  • Change in hemoglobin(48 hours after cesarean)
  • Existence of cesarean scar defect(6 months after cesarean)
  • Width of defect(6 months after cesarean)
  • Blood product transfusion(One week after cesarean)
  • Maternal infectious morbidity(Six weeks after cesarean)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ragıp Atakan Al

Proffesor in dept. of obstetrics and gynecology

Ataturk University

Study Sites (1)

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