Cesarean Scar Defect Formation After First Cesarean Section.

• Conditions: Cesarean Section Complications; Cesarean Wound; Dehiscence; Cesarean Wound Disruption
• Interventions: Other: Transvaginal sonography at six months after cesarean section; Other: Transvaginal sonography at twelve months after cesarean section

• Registration Number: NCT03966001
• Lead Sponsor: Uludag University

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.

Study Timeline

• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-05-24
• Study First Posted: 2019-05-29
• Status Verified: 2019-06
• Study Start: 2019-06-25
• Last Update Submitted: 2019-06-25
• Last Update Posted: 2019-06-26
• Primary Completion: 2020-06-01
• Study Completion: 2020-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Emergency Cesarean Group	Transvaginal sonography at twelve months after cesarean section	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.
Emergency Cesarean Group	Transvaginal sonography at six months after cesarean section	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.
Planned Cesarean Group	Transvaginal sonography at six months after cesarean section	Pregnant women undergoing a planned cesarean section at 38-42 gestational week.
Planned Cesarean Group	Transvaginal sonography at twelve months after cesarean section	Pregnant women undergoing a planned cesarean section at 38-42 gestational week.

Primary Outcome Measures

Name	Time	Method
Cesarean Scar Defect (Niche)	10 minutes	The presence of a "niche" at the site of cesarean delivery scar diagnosed at the time of transvaginal ultrasonography

Secondary Outcome Measures

Name	Time	Method
Postmenstrual spotting	7-10 days	Any vaginal bleeding that occurs after the usual menstrual period.

Trial Locations

Locations (1)

Uludag University Hospital, Department of Obstetrics and Gynecology; 🇹🇷 Bursa, Ozluce, Turkey