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Completed

NCT Number: NCT06761495

Can Cesarean Scar Defects be Prevented?

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.

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Key information

Conditions

Isthmocele

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gazıosmanpasa Unıversity

Tokat Province, 60090, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

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

Primary outcomes

  1. Isthmocele was be evaluated

    Time frame: Three months postoperatively

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

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

Is Isthmosel Becoming History? The Effect of Three Different Uterotomy Closure

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jan 7, 2025
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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