Cesarean Scar Defect Formation After First Cesarean Section.

June 25, 2019 updated by: Adnan Orhan, Uludag University

Formation of the Cesarean Scar Defect After the First Cesarean. A Prospective Observational Study of Planned Versus Emergency Cesarean Sections

This study is a prospective observational study which will monitor how cesarean section in the first pregnancy will develop a cesarean scar defect. Patients with planned cesarean section in their first pregnancy and those with an emergency cesarean section will be monitored for one year.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Cesarean scar defects, which may develop after cesarean deliveries, are associated with menstrual bleeding problems, infertility, and poor obstetric outcomes. No matter how excellent and standard surgical technique is applied, scar defects may develop after cesarean section. However, when cesarean operation decision is taken, the existing operational conditions can affect the formation of cesarean scar defect in the future. Although the surgical technique is the same, a planned cesarean operation and an emergency cesarean section may differ for a future cesarean scar defect that may develop in the future.

Study Type

Observational

Enrollment (Anticipated)

250

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

Study Contact Backup

Study Locations

  • Turkey
    • Ozluce
      • Bursa, Ozluce, Turkey, 16059
        • Recruiting
        • Uludag University Hospital, Department of Obstetrics and Gynecology
        • Contact:
        • Contact:

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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

The study population consists of pregnant patients who are in their 38-42th gestational weeks and who undergo planned or emergency cesarean section.

Description

Inclusion Criteria:

  • 18-45-year-old patients
  • Patients who have undergone a planned or emergency cesarean section within the 38-42th gestational week.

Exclusion Criteria:

  • Spontaneous vaginal birth
  • Preterm birth
  • Pregnant women with an obstetrical or gynecological complication.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Planned Cesarean Group
Pregnant women undergoing a planned cesarean section at 38-42 gestational week.
Other: Transvaginal sonography at six months after cesarean section
In the sixth month after cesarean section, Women in both groups will undergo a detailed pelvic examination and transvaginal ultrasonographic evaluation for the cesarean scar defect.
Other Names:
  • Transvaginal sonography 6th month after C/S
Other: Transvaginal sonography at twelve months after cesarean section
In the twelfth month after cesarean section, Women in both groups will undergo a detailed pelvic examination and transvaginal ultrasonographic evaluation for the cesarean scar defect.
Other Names:
  • Transvaginal sonography 12th month after C/S
Emergency Cesarean Group
Pregnant women who are planning to give normal birth between 38-42 weeks of gestation but have to been performed an urgent cesarean section due to an emergency such as acute fetal distress, cephalo-pelvic disproportion or another obstetrical condition.
Other: Transvaginal sonography at six months after cesarean section
In the sixth month after cesarean section, Women in both groups will undergo a detailed pelvic examination and transvaginal ultrasonographic evaluation for the cesarean scar defect.
Other Names:
  • Transvaginal sonography 6th month after C/S
Other: Transvaginal sonography at twelve months after cesarean section
In the twelfth month after cesarean section, Women in both groups will undergo a detailed pelvic examination and transvaginal ultrasonographic evaluation for the cesarean scar defect.
Other Names:
  • Transvaginal sonography 12th month after C/S

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cesarean Scar Defect (Niche)
Time Frame: 10 minutes
The presence of a "niche" at the site of cesarean delivery scar diagnosed at the time of transvaginal ultrasonography
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postmenstrual spotting
Time Frame: 7-10 days
Any vaginal bleeding that occurs after the usual menstrual period.
7-10 days

Collaborators and Investigators

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

Sponsor

Uludag University

Investigators

  • Study Director: Gurkan Uncu, Prof., Uludag University Hospital, 16059, Bursa, Turkey
  • Principal Investigator: Bilge Cetinkaya Demır, Assoc.Prof., Uludag University Hospital, 16059, Bursa, Turkey

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)

June 25, 2019

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

December 15, 2020

Study Registration Dates

First Submitted

May 24, 2019

First Submitted That Met QC Criteria

May 24, 2019

First Posted (Actual)

May 29, 2019

Study Record Updates

Last Update Posted (Actual)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 25, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UU-SUAM-2019-8/34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual participant data for all primary and secondary outcomes will be made available.

IPD Sharing Time Frame

Data will be available within nine months after the study completion.

IPD Sharing Access Criteria

Data access requests will be reviewed by an external independent review panel. Requesters will be required to sign a data access agreement form.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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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