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Can Cesarean Scar Defects be Prevented?

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06761495
Enrollment
120
Registered
2025-01-07
Start date
2022-05-01
Completion date
2023-01-30
Last updated
2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Isthmocele

Keywords

niche, baseball suturing, uterotomy, caesarean section

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).

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

Sponsors

Istinye University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Isthmocele was be evaluatedThree months postoperativelyThe presence and anatomical location of isthmocele were be evaluated by ultrasonography.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026