Cesarean Scar Defect Formation After First Cesarean Section.

NCT ID: NCT03966001

Last Updated: 2019-06-26

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-25

Study Completion Date

2020-12-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cesarean Section Complications Cesarean Wound Disruption Cesarean Wound; Dehiscence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Transvaginal sonography 6th month after C/S Transvaginal sonography 12th month after C/S

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Uludag University

OTHER

Sponsor Role lead

Responsible Party

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Adnan Orhan

Medical Doctor, Researcher, Obstetrician and Gynecologist

Responsibility Role PRINCIPAL_INVESTIGATOR

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)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Adnan Orhan, M.D.

Role: CONTACT

+905056337102

Isil Kasapoglu, M.D

Role: CONTACT

+905305455848

Facility Contacts

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Adnan Orhan, M.D.

Role: primary

+90 505 6337102

Ebru Sakar, M.D

Role: backup

+90 507 8517109

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.

Reference Type BACKGROUND
PMID: 29754409 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29024799 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28661021 (View on PubMed)

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.

Reference Type RESULT
PMID: 30240650 (View on PubMed)

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.

Reference Type RESULT
PMID: 27867050 (View on PubMed)

Other Identifiers

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UU-SUAM-2019-8/34

Identifier Type: -

Identifier Source: org_study_id

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