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Clinical Trials/NCT03644433
NCT03644433UnknownNot Applicable

Impact of Single Layer Versus Double Layer Uterine Closure on the Cesarean Scar Healing

Ataturk University2 sites in 2 countries70 target enrollmentStarted: August 23, 2018Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
70
Locations
2
Primary Endpoint
residual myometrial thickness
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

We compares two techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. We will evaluate myometrial thickness 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

  • Operation time(10 minute after cesarean completed)
  • Maternal infectious morbidity(six weeks after cesarean)
  • residual myometrial thickness(6 weeks after cesarean)
  • Existence of cesarean scar defect(6 weeks after cesarean)
  • Healing ratio(6 weeks after cesarean)
  • Change in hemoglobin(48 hours after cesarean)
  • Blood product transfusion(One week after cesarean)
  • Length of hospitalization(One month after cesarean)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ragıp Atakan Al

Professor in obstetrics And gynecology

Ataturk University

Study Sites (2)

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