Comparison the Effect of Uterine Closure Technique Difference on Uterine Niche After Caesarean Delivery.

March 11, 2021 updated by: Ergul Demircivi Bor, Kanuni Sultan Suleyman Training and Research Hospital
Caesarean section scar may have result as isthmocele or scar detachment during pregnancy which is in few years after previous delivery. Uterine niche is the most effectively used measurement side of uterus to estimate for these detachment complications. The aim of this study is to support this niche site by supporting the classical uterine closure technique.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cesarean delivery rate continues to increase in world in concern with uterine scar complications as placental invasion abnormalities, isthmocele or previous scar detachment during pregnancy (post surgical long term complications). Uterine niche is the presence of a hypoechoic area within the myometrium on the lower uterine segment, showing a defect of the myometrium at the site of a previous cesarean delivery. Some surgical techniques have been trying to support this area to prevent the post surgical long term complications. In this study the investigators have been trying to find out a new technique by applying supporting sutures during uterine closure in cesarean section. Three months after the surgery, the uterine niche measurement will be examined with ultrasonography for both study and classical groups and results will be compared between the groups.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Ergul Demircivi Bor
  • Phone Number: 360206 +902166065200
  • Email: drergul@yahoo.com

Study Locations

  • Turkey
    • Kadikoy
      • Istanbul, Kadikoy, Turkey, 34722
        • Recruiting
        • Prof Dr Suleyman Yalcin Goztepe City Hospital
        • Contact:
        • Principal Investigator:
          • Ergul Demircivi Bor
        • Sub-Investigator:
          • Mehmet Kucukbas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Primigravid elective caesarian delivery candidates
  • The participants will have not any uterine contraction or cervical dilatation before delivery.
  • Having no systemic or obstetric illnesses
  • Participants who are accept to participate in this study with their written consent.

Exclusion Criteria:

  • Previous caesarian delivery
  • Having uterine contraction or cervical dilatation
  • Smoking cigarettes
  • Having systemic or obstetric illnesses

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Classical caesarean group
Care providers are applying standard caesarean procedure for participants.
EXPERIMENTAL: Study caesarean group
Care providers are applying additional sutures to standard caesarean procedure for participants.
Other: Suture technique
We wil apply additional sutures to classical caesarean procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants for each group for study
Time Frame: Up to 9 months
We will try to reach fifty participants for each group (study group as classical cesarean with supporting suture and control group as classical cesarean) . When we reach to all participants we will stop to enroll the participants.
Up to 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Investigators

  • Principal Investigator: Ergul Demircivi Bor, Prof Dr Suleyman Yalcin Goztepe City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2021

Primary Completion (ANTICIPATED)

July 31, 2021

Study Completion (ANTICIPATED)

October 31, 2021

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (ACTUAL)

March 16, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021/0077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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