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
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 Locations
-
-
Ozluce
-
Bursa, Ozluce, Turkey, 16059
- Recruiting
- Uludag University Hospital, Department of Obstetrics and Gynecology
-
Contact:
- Adnan Orhan, M.D.
- Phone Number: +90 505 6337102
- Email: dr.adnan.orhan@hotmail.com
-
Contact:
- Ebru Sakar, M.D
- Phone Number: +90 507 8517109
- Email: ebru_sakar@hotmail.com
-
-
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.
|
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:
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:
|
|
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.
|
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:
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:
|
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
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
- Antila-Langsjo R, Maenpaa JU, Huhtala H, Tomas E, Staff S. Comparison of transvaginal ultrasound and saline contrast sonohysterography in evaluation of cesarean scar defect: a prospective cohort study. Acta Obstet Gynecol Scand. 2018 Sep;97(9):1130-1136. doi: 10.1111/aogs.13367. Epub 2018 May 29.
- Setubal A, Alves J, Osorio F, Guerra A, Fernandes R, Albornoz J, Sidiroupoulou Z. Treatment for Uterine Isthmocele, A Pouchlike Defect at the Site of a Cesarean Section Scar. J Minim Invasive Gynecol. 2018 Jan;25(1):38-46. doi: 10.1016/j.jmig.2017.09.022. Epub 2017 Oct 9.
- Cali G, Timor-Tritsch IE, Palacios-Jaraquemada J, Monteaugudo A, Buca D, Forlani F, Familiari A, Scambia G, Acharya G, D'Antonio F. Outcome of Cesarean scar pregnancy managed expectantly: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Feb;51(2):169-175. doi: 10.1002/uog.17568.
- Antila-Langsjo RM, Maenpaa JU, Huhtala HS, Tomas EI, Staff SM. Cesarean scar defect: a prospective study on risk factors. Am J Obstet Gynecol. 2018 Nov;219(5):458.e1-458.e8. doi: 10.1016/j.ajog.2018.09.004. Epub 2018 Sep 18.
- Ades A, Parghi S. Laparoscopic Resection of Cesarean Scar Ectopic Pregnancy. J Minim Invasive Gynecol. 2017 May-Jun;24(4):533-535. doi: 10.1016/j.jmig.2016.11.006. Epub 2016 Nov 17.
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
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.