CClinicalTrials.gg
CompletedNCT06761495Updated Jan 7, 2025

Can Cesarean Scar Defects be Prevented?

An interventional study of Baseball Suturing Technique and Single-Layer Locked Continuous Suturing Technique in Isthmocele, sponsored by Istinye University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-07.

Sponsored by Istinye University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled May 2022, registered Dec 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
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Study 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.

Read the 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).

02

Conditions studied

  • Isthmocele

Keywords

  • niche
  • baseball suturing
  • uterotomy
  • caesarean section
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In context

Lead sponsor

Istinye University is the lead sponsor of 207 studies on the registry; 88 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    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.

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

  • Active comparator
    Residual myometrial thickness

    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

  • ProcedureBaseball 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

  • ProcedureSingle-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

  • ProcedureSingle-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

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What researchers measure

Primary outcomes

  1. Isthmocele was be evaluated

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

    Time frame: Three months postoperatively

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Study locations

1 site
  • Gazıosmanpasa Unıversity
    Tokat, 60090, Turkey
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References and documents

Individual participant data

Plan to share: Yes

Supporting information: Icf

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06761495
Lead sponsor
Istinye University
Responsible party
Sponsor
First posted
Jan 7, 2025
Start date
May 1, 2022
Primary completion
Oct 30, 2022
Completion
Jan 30, 2023
Last update
Jan 7, 2025

Study contacts

Neset Gumusburun, M.D.
principal investigator · Gazıosmanpasa Unıversity

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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