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Evaluation of Cesarean Scar After Three Different Uterine Closure Technis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03915847
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : May 11, 2020
Sponsor:
Information provided by (Responsible Party):
Ragıp Atakan Al, Ataturk University

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.

Condition or disease Intervention/treatment Phase
Cesarean Section, Repeated Cesarean, Uterine Scar Thickness Cesarean, Residual Myometrial Thickness Procedure: Single layer closure Procedure: Double layer closure Procedure: Doble layer closure with trimming Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Cesarean Scar After Three Different Uterine Closure Technis: A Randomised Trial
Actual Study Start Date : April 16, 2019
Actual Primary Completion Date : April 16, 2020
Actual Study Completion Date : April 16, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

Arm Intervention/treatment
Active Comparator: Single layer closure Procedure: Single layer closure
Uterine incision will be approximated with continuous unlocked suture, including a narrow band of the endometrial layer, without trimming incision edges.

Active Comparator: Double layer closure Procedure: Double layer closure
The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.

Active Comparator: Doble layer closure with trimming Procedure: Doble layer closure with trimming
Uterine incision will be trimmed and old scar tissue will be removed. The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.




Primary Outcome Measures :
  1. Residual myometrial thickness [ Time Frame: 6 months after cesarean ]
    Myometrial thickness at the uterine scar by transvaginal ultrasound


Secondary Outcome Measures :
  1. Existence of cesarean scar defect [ Time Frame: 6 months after cesarean ]
    The presence or absence of a cesarean scar defect that was defined as any unechogenic area visualised by transvaginal ultrasound at the site of the cesarean scar with a depth of at least 2 mm.

  2. Width of defect [ Time Frame: 6 months after cesarean ]
    In a sagittal plane, the width at base of defect

  3. Depth of defect (niche) [ Time Frame: 6 months after cesarean ]
    In a sagittal plane, the distance from the base lining of the endometrium to the apex

  4. Operation time [ Time Frame: 10 minute after cesarean completed ]
    Skin-to-skin operation time

  5. Change in hemoglobin [ Time Frame: 48 hours after cesarean ]
    Difference in haemoglobin measured preoperatively and postoperatively 48 hours

  6. Blood product transfusion [ Time Frame: One week after cesarean ]
    Unite number of transfused packed erythrocyte

  7. Maternal infectious morbidity [ Time Frame: Six weeks after cesarean ]
    Prevalence of postpartum endometritis, skin wound dehiscence and post operative fever.

  8. Length of hospitalization [ Time Frame: One month after cesarean ]
    Duration in days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03915847


Locations
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Turkey
Ataturk University Hospital
Erzurum, Turkey
Sponsors and Collaborators
Ataturk University
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Responsible Party: Ragıp Atakan Al, Proffesor in dept. of obstetrics and gynecology, Ataturk University
ClinicalTrials.gov Identifier: NCT03915847    
Other Study ID Numbers: ATA35
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: May 11, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes