Clinical trial NCT03966001: Cesarean Scar Defect Formation After First Cesarean Section.
Official title: Formation of the Cesarean Scar Defect After the First Cesarean. A Prospective Observational Study of Planned Versus Emergency Cesarean Sections
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cesarean Section Complications
Cesarean Wound Disruption
Cesarean Wound; Dehiscence
Keywords: Cesarean scar pregnancy
Isthmocele
Uterine niche
Cesarean scar defect
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cesarean Scar Defect (Niche)
timeFrame: 10 minutes
Secondary outcomes:
measure: Postmenstrual spotting
timeFrame: 7-10 days
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Uludag University Hospital, Department of Obstetrics and Gynecology
state: Ozluce
Study officials:
affiliation: Uludag University Hospital, 16059, Bursa, Turkey
name: Gurkan Uncu, Prof.
role: STUDY_DIRECTOR
affiliation: Uludag University Hospital, 16059, Bursa, Turkey
name: Bilge Cetinkaya Demır, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.