Can Cesarean Scar Defects be Prevented?

NCT ID: NCT06761495

Last Updated: 2025-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2023-01-30

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).

Conditions

Isthmocele

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Isthmosel (caesarean scar defect )

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.

Group Type: ACTIVE_COMPARATOR

Baseball Suturing Technique

Intervention Type: PROCEDURE

(Baseball Suturing Technique): A corner suture was placed at the right corner of the incision. Next, the second stitch was placed at the apex of the left corner and tied with a knot. Then, the free end of the suture was cut and running baseball stitch pattern was started. The suturing pattern was performed by taking bites from the inside out through the upper and lower lips of the wound at approximately 1 cm intervals with a 1 cm margin from the wound edges

Single-Layer Locked Continuous Suturing Technique

Intervention Type: PROCEDURE

(Single-Layer Locked Continuous Suturing Technique): A corner suture was placed at the right corner of the incision. Next, the second stitch was placed at the apex of the left corner and tied with a knot. Then, the free end of the suture was cut and single-layer-locked continuous suturing was started. The suturing pattern was performed by taking bites from outside to inside through the lower lip and inside to outside through the upper lip of the wound. Each time, a lock was formed by passing through the loop formed by the previous suture. The suturing was performed at approximately 1 cm intervals with a 1 cm margin from the wound edges

Single-Layer Unlocked Continuous Suturing Technique

Intervention Type: PROCEDURE

(Single-Layer Unlocked Continuous Suturing Technique): The uterotomy line was closed in a single-layer continuous suturing pattern that is explained above as group 2 but without passing the needle through the loop formed by the previous sutu

Residual myometrial thickness

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

Group Type: ACTIVE_COMPARATOR

Baseball Suturing Technique

Intervention Type: PROCEDURE

(Baseball Suturing Technique): A corner suture was placed at the right corner of the incision. Next, the second stitch was placed at the apex of the left corner and tied with a knot. Then, the free end of the suture was cut and running baseball stitch pattern was started. The suturing pattern was performed by taking bites from the inside out through the upper and lower lips of the wound at approximately 1 cm intervals with a 1 cm margin from the wound edges

Single-Layer Locked Continuous Suturing Technique

Intervention Type: PROCEDURE

(Single-Layer Locked Continuous Suturing Technique): A corner suture was placed at the right corner of the incision. Next, the second stitch was placed at the apex of the left corner and tied with a knot. Then, the free end of the suture was cut and single-layer-locked continuous suturing was started. The suturing pattern was performed by taking bites from outside to inside through the lower lip and inside to outside through the upper lip of the wound. Each time, a lock was formed by passing through the loop formed by the previous suture. The suturing was performed at approximately 1 cm intervals with a 1 cm margin from the wound edges

Single-Layer Unlocked Continuous Suturing Technique

Intervention Type: PROCEDURE

(Single-Layer Unlocked Continuous Suturing Technique): The uterotomy line was closed in a single-layer continuous suturing pattern that is explained above as group 2 but without passing the needle through the loop formed by the previous sutu

Interventions

Baseball Suturing Technique

(Baseball Suturing Technique): A corner suture was placed at the right corner of the incision. Next, the second stitch was placed at the apex of the left corner and tied with a knot. Then, the free end of the suture was cut and running baseball stitch pattern was started. The suturing pattern was performed by taking bites from the inside out through the upper and lower lips of the wound at approximately 1 cm intervals with a 1 cm margin from the wound edges

Intervention Type: PROCEDURE

Single-Layer Locked Continuous Suturing Technique

(Single-Layer Locked Continuous Suturing Technique): A corner suture was placed at the right corner of the incision. Next, the second stitch was placed at the apex of the left corner and tied with a knot. Then, the free end of the suture was cut and single-layer-locked continuous suturing was started. The suturing pattern was performed by taking bites from outside to inside through the lower lip and inside to outside through the upper lip of the wound. Each time, a lock was formed by passing through the loop formed by the previous suture. The suturing was performed at approximately 1 cm intervals with a 1 cm margin from the wound edges

Intervention Type: PROCEDURE

Single-Layer Unlocked Continuous Suturing Technique

(Single-Layer Unlocked Continuous Suturing Technique): The uterotomy line was closed in a single-layer continuous suturing pattern that is explained above as group 2 but without passing the needle through the loop formed by the previous sutu

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Istinye University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neset Gumusburun, M.D.

Role: PRINCIPAL_INVESTIGATOR

Gazıosmanpasa Unıversity

Locations

Gazıosmanpasa Unıversity

Tokat Province, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MLP Tokat

Identifier Type: -

Identifier Source: org_study_id