Can Cesarean Scar Defects be Prevented?

Not Applicable

Completed

• Conditions: Isthmocele

• Registration Number: NCT06761495
• Lead Sponsor: Istinye University

Brief Summary

In this study, uterotomy after cesarean section was performed using 3 different suture techniques and aimed to demonstrate the potential of the baseball suture technique to prevent the isthmusel complication known as cesarean scar defect.

Detailed Description

An isthmocoele or cesarean scar defect is a pit-like defect in the myometrium at the isthmic level, thought to be the result of inadequate healing of the uterine incision after cesarean section. It is important not to underestimate isthmocele and to take preventive measures as it can lead to serious gynecologic and obstetric complications. However, which suturing technique is best in preventing isthmocele formation has not yet been established. The aim of this study was to compare the effects of 3 different uterine closure techniques on isthmocele formation during cesarean section.

In this study, a total of 120 term (\>37 weeks) pregnant women with no previous cesarean section and scheduled for primary cesarean section will be randomized preoperatively to 3 different uterotomy closure techniques (baseball, single-lock and non-single-lock groups).

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2022-10-30
• Study Completion: 2023-01-30
• Status Verified: 2024-12
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-30
• Last Update Submitted: 2024-12-30
• Study First Posted: 2025-01-07
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

• Presence of regular contractions in the uterus
• Cervical dilatation of more than 4 cm, indicating the onset of the active phase of labour
• Placental abnormalities
• Previous uterine surgery
• Multiple pregnancy
• Premature rupture of membranes
• Chorioamnionitis
• Preoperative haemoglobin level below 10g/dl
• Body mass index (BMI) above 35kg/m2
• Any comorbidity (e.g. diabetes, hypertension, pre-eclampsia, eclampsia)
• Smoking and/or alcohol use
• The need for a blood transfusion.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Isthmocele was be evaluated	Three months postoperatively	The presence and anatomical location of isthmocele were be evaluated by ultrasonography.

Trial Locations

Locations (1)

Gazıosmanpasa Unıversity; 🇹🇷 Tokat, Turkey