Cesarean Scar Defect Formation After First Cesarean Section.
NCT ID: NCT03966001
Last Updated: 2019-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
250 participants
OBSERVATIONAL
2019-06-25
2020-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Planned Cesarean Group
Pregnant women undergoing a planned cesarean section at 38-42 gestational week.
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.
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.
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.
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.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who have undergone a planned or emergency cesarean section within the 38-42th gestational week.
Exclusion Criteria
* Preterm birth
* Pregnant women with an obstetrical or gynecological complication.
18 Years
45 Years
FEMALE
Yes
Sponsors
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Uludag University
OTHER
Responsible Party
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Adnan Orhan
Medical Doctor, Researcher, Obstetrician and Gynecologist
Principal Investigators
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Gurkan Uncu, Prof.
Role: STUDY_DIRECTOR
Uludag University Hospital, 16059, Bursa, Turkey
Bilge Cetinkaya Demır, Assoc.Prof.
Role: PRINCIPAL_INVESTIGATOR
Uludag University Hospital, 16059, Bursa, Turkey
Locations
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Uludag University Hospital, Department of Obstetrics and Gynecology
Bursa, Ozluce, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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UU-SUAM-2019-8/34
Identifier Type: -
Identifier Source: org_study_id
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