Can Cesarean Scar Defects be Prevented?

NCT06761495 | Completed

• 1 other identifier: MLP Tokat
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Isthmocele

Keywords

niche; baseball suturing; uterotomy; caesarean section

Outcome Measures

Primary Outcomes (1)

• Isthmocele was be evaluated

  The presence and anatomical location of isthmocele were be evaluated by ultrasonography.

  Three months postoperatively

Study Arms (2)

Isthmosel (caesarean scar defect )

ACTIVE COMPARATOR

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.

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

Residual myometrial thickness

ACTIVE COMPARATOR

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

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

Interventions

Baseball Suturing Technique 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

Isthmosel (caesarean scar defect ); Residual myometrial thickness

Single-Layer Locked Continuous Suturing Technique 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

Isthmosel (caesarean scar defect ); Residual myometrial thickness

Single-Layer Unlocked Continuous Suturing Technique 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

Isthmosel (caesarean scar defect ); Residual myometrial thickness

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Gazıosmanpasa Unıversity

Tokat Province, 60090, Turkey (Türkiye)

Location

Study Officials

• Neset Gumusburun, M.D.

  Gazıosmanpasa Unıversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Caesarean section patients were eligible for the study and randomized preoperatively into 3 different uterotomy closure techniques (baseball, single-locked and single-unlocked groups). In all 3 groups, No. 1 absorbable multiflament polyglactin 910(Vicryl, Ethicon Inc, Somerville, NJ, USA) suture thread was used to close the uterine incision. When necessary, haemostatic additional sutures were applied using the same material.

Study Record Dates

• First Submitted: December 19, 2024
• First Posted: January 7, 2025
• Study Start: May 1, 2022
• Primary Completion: October 30, 2022
• Study Completion: January 30, 2023
• Last Updated: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: The data that support the findings of this study are available on request from corresponding author.

Locations

TU (1)