Can Cesarean Scar Defects be Prevented?

Istinye University

Status: Completed

Conditions: Isthmocele

Treatments: Procedure: Single-Layer Unlocked Continuous Suturing Technique; Procedure: Baseball Suturing Technique; Procedure: Single-Layer Locked Continuous Suturing Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06761495

MLP Tokat

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women undergoing C/S for the first time
• 37 weeks < gestation (term pregnancies)

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

Isthmosel (caesarean scar defect )

Active Comparator group

Description:

Isthmosel or caesarean scar defect is a poch-like defect in the myometrium at the isthmic level that is thought that it might occur as a result of insufficient healing process of the uterine incision after caesarean section.

Treatment:

Procedure: Single-Layer Locked Continuous Suturing Technique

Procedure: Baseball Suturing Technique

Procedure: Single-Layer Unlocked Continuous Suturing Technique

Residual myometrial thickness

Active Comparator group

Description:

Three months after the operation, residual myometrial thickness localization was evaluated by ultrasonography.

Treatment:

Procedure: Single-Layer Locked Continuous Suturing Technique

Procedure: Baseball Suturing Technique

Procedure: Single-Layer Unlocked Continuous Suturing Technique