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Single or Double-layer Uterine Closure Techniques

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: NCT03629028
Recruitment Status : Completed
First Posted : August 14, 2018
Results First Posted : May 1, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Safak Baran Yilmaz, Baskent University

Brief 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.

Condition or disease Intervention/treatment Phase
Uterine Scar Cesarean Section Complications Cesarean Section; Dehiscence Diagnostic Test: Residual myometrium thickness Diagnostic Test: Niche Presence Diagnostic Test: Adjacent myometrium thickness Diagnostic Test: Niche Measurements (depth of niche, width of niche, length of niche) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 282 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective Randomised Trial
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Single or Double-layer Uterine Closure Techniques Following Cesarean: An Ongoing Debate
Actual Study Start Date : August 18, 2018
Actual Primary Completion Date : August 18, 2018
Actual Study Completion Date : March 10, 2020

Arm Intervention/treatment
Active Comparator: Single Layer
Diagnostic Test: Niche Presence in 6 to 9 months Diagnostic Test: Niche Measurements (depth of niche, the length of niche, the width of the niche in the transverse plane) Diagnostic Test: Residual myometrium thickness Diagnostic Test: Adjacent myometrium thickness Symptoms: postmenstrual bleeding/dysmenorrhea
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.

Active Comparator: Double Layer
Diagnostic Test: Niche Presence in 6 to 9 months Diagnostic Test: Niche Measurements (depth of niche, the length of niche, the width of the niche in the transverse plane) Diagnostic Test: Residual myometrium thickness Diagnostic Test: Adjacent myometrium thickness Symptoms: postmenstrual bleeding/dysmenorrhea
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.




Primary Outcome Measures :
  1. Number of Participants With Niche Visualized by Saline Infusion Sonography [ Time Frame: 6 to 9 months ]
    The presence of niche in incision line visualized by saline infusion sonography

  2. Median Depth of Niche [ Time Frame: 6-9 months ]
    with saline infusion sonohysterography

  3. Median Length of Niche [ Time Frame: 6-9 months ]
    by saline infusion sonohysterography

  4. Median Width of Niche in Transverse Plane [ Time Frame: 6-9 months ]
    median width of niche in transverse plane by saline infusion sonohysterograhpy


Secondary Outcome Measures :
  1. Residual Myometrium Thickness - 6 to 9 Months [ Time Frame: 6 to 9 months ]
    The residual myometrium thickness in incision line measured by saline infusion sonography

  2. Adjacent Myometrium Thickness [ Time Frame: 6 to 9 months ]
    Adjacent myometrium thickness out of incision line measured by saline infusion sonography



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only women who underwent cesarean section
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary cesarean, singleton pregnancy,

Exclusion Criteria:

  • Multiple pregnancy, History of any uterine surgery, wound healing diseases (insulin dependent diabetes mellitus, rheumatoid arthritis, systemic lupus erythematous, inflammatory bowel disease)

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): NCT03629028


Locations
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Turkey
Baskent University Adana Seyhan Uygulama Hastanesi
Adana, Turkey
Sponsors and Collaborators
Safak Baran Yilmaz
Investigators
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Principal Investigator: Şafak YILMAZ BARAN, M.D. Baskent University Department of Obstetrics and Gynecology
  Study Documents (Full-Text)

Documents provided by Safak Baran Yilmaz, Baskent University:
Publications:
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Responsible Party: Safak Baran Yilmaz, Specialist Dr. Şafak YILMAZ BARAN M.D., Baskent University
ClinicalTrials.gov Identifier: NCT03629028    
Other Study ID Numbers: KA 18/71
First Posted: August 14, 2018    Key Record Dates
Results First Posted: May 1, 2020
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Safak Baran Yilmaz, Baskent University:
cesarean section, niche, isthmocele, uterine closure