Single or Double-layer Uterine Closure Techniques

NCT03629028 | Completed Results

• 1 other identifier: KA 18/71
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Scar; Cesarean Section Complications; Cesarean Section; Dehiscence

Keywords

cesarean section, niche, isthmocele, uterine closure

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Niche Visualized by Saline Infusion Sonography

  The presence of niche in incision line visualized by saline infusion sonography

  6 to 9 months

• Median Depth of Niche

  with saline infusion sonohysterography

  6-9 months

• Median Length of Niche

  by saline infusion sonohysterography

  6-9 months

• Median Width of Niche in Transverse Plane

  median width of niche in transverse plane by saline infusion sonohysterograhpy

  6-9 months

Secondary Outcomes (2)

• Residual Myometrium Thickness - 6 to 9 Months

  6 to 9 months

• Adjacent Myometrium Thickness

  6 to 9 months

Study Arms (2)

Single Layer

ACTIVE COMPARATOR

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; Diagnostic Test: Niche Presence; Diagnostic Test: Adjacent myometrium thickness; Diagnostic Test: Niche Measurements (depth of niche, width of niche, length of niche)

Double Layer

ACTIVE COMPARATOR

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; Diagnostic Test: Niche Presence; Diagnostic Test: Adjacent myometrium thickness; Diagnostic Test: Niche Measurements (depth of niche, width of niche, length of niche)

Interventions

Residual myometrium thickness DIAGNOSTIC_TEST

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.

Double Layer; Single Layer

Niche Presence DIAGNOSTIC_TEST

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.

Double Layer; Single Layer

Adjacent myometrium thickness DIAGNOSTIC_TEST

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.

Double Layer; Single Layer

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

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.

Double Layer; Single Layer

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Only women who underwent cesarean section
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Primary cesarean, singleton pregnancy,

You may not qualify if:

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

Sponsors & Collaborators

• Safak Baran Yilmaz: lead

Study Sites (1)

Baskent University Adana Seyhan Uygulama Hastanesi

Adana, Turkey (Türkiye)

Location

Related Publications (1)

• Di Spiezio Sardo A, Saccone G, McCurdy R, Bujold E, Bifulco G, Berghella V. Risk of Cesarean scar defect following single- vs double-layer uterine closure: systematic review and meta-analysis of randomized controlled trials. Ultrasound Obstet Gynecol. 2017 Nov;50(5):578-583. doi: 10.1002/uog.17401. Epub 2017 Oct 9.

  PMID: 28070914 BACKGROUND

Results Point of Contact

• Title: Şafak Yılmaz Baran, MD
• Organization: Principal investigator of the research

safakyilmazbaran@gmail.com

+903224586868

Study Officials

• Şafak YILMAZ BARAN, M.D.

  Baskent University Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist Dr. Şafak YILMAZ BARAN M.D.

Model Details: Prospective Randomised Trial

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 14, 2018
• Study Start: August 18, 2018
• Primary Completion: August 18, 2018
• Study Completion: March 10, 2020
• Last Updated: May 1, 2020
• Results First Posted: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)