Cesarean Scar Defect Formation After First Cesarean Section.

Cesarean Section Complications Clinical Trial

Official title:

Formation of the Cesarean Scar Defect After the First Cesarean. A Prospective Observational Study of Planned Versus Emergency Cesarean Sections

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03966001
• Other study ID #: UU-SUAM-2019-8/34
• Status: Recruiting
• Start date: June 25, 2019
• Est. completion date: December 15, 2020

Study information

• Verified date: June 2019
• Source: Uludag University
• Contact: Adnan Orhan, M.D.
• Phone: +905056337102
• Email: dr.adnan.orhan[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 15, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section Complications
• Cesarean Wound Disruption
• Cesarean Wound; Dehiscence
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Turkey	Uludag University Hospital, Department of Obstetrics and Gynecology	Bursa	Ozluce

Sponsors (1)

Lead Sponsor	Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

Antila-Långsjö R, Mäenpää JU, Huhtala H, Tomás 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. — View Citation

Antila-Långsjö RM, Mäenpää JU, Huhtala HS, Tomás 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. — View Citation

Calì 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. Review. — View Citation

Setubal A, Alves J, Osório 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Postmenstrual spotting	Any vaginal bleeding that occurs after the usual menstrual period.	7-10 days