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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Planned Cesarean Group | Pregnant women undergoing a planned cesarean section at 38-42 gestational week. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transvaginal sonography at six months after cesarean section | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cesarean Scar Defect (Niche) | The presence of a "niche" at the site of cesarean delivery scar diagnosed at the time of transvaginal ultrasonography | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Postmenstrual spotting | Any vaginal bleeding that occurs after the usual menstrual period. | 7-10 days |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant women at 38-42th gestational weeks.
The study population consists of pregnant patients who are in their 38-42th gestational weeks and who undergo planned or emergency cesarean section.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adnan Orhan, M.D. | Contact | +905056337102 | dr.adnan.orhan@hotmail.com | |
| Isil Kasapoglu, M.D | Contact | +905305455848 | kasapogluisil@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gurkan Uncu, Prof. | Uludag University Hospital, 16059, Bursa, Turkey | Study Director |
| Bilge Cetinkaya Demır, Assoc.Prof. | Uludag University Hospital, 16059, Bursa, Turkey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uludag University Hospital, Department of Obstetrics and Gynecology | Recruiting | Bursa | Ozluce | 16059 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29754409 | Background | 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. | |
| 29024799 | Background |
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Deidentified individual participant data for all primary and secondary outcomes will be made available.
Data will be available within nine months after the study completion.
Data access requests will be reviewed by an external independent review panel. Requesters will be required to sign a data access agreement form.
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| Transvaginal sonography at twelve months after cesarean section | 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. |
|
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| 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. |
| 28661021 | Background | 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. |
| 30240650 | Result | 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. |
| 27867050 | Result | 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. |