IsthmoceleNCT06761495
Can Cesarean Scar Defects be Prevented?
A study testing Baseball Suturing Technique, Single-Layer Locked Continuous Suturing Technique and Single-Layer Unlocked Continuous Suturing Technique in people with Isthmocele, run by Istinye University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Isthmocele
- What is being tested?
- Baseball Suturing Technique, Single-Layer Locked Continuous Suturing Technique and Single-Layer Unlocked Continuous Suturing Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women undergoing C/S for the first time
- 37 weeks < gestation (term pregnancies)
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazıosmanpasa Unıversity
Tokat Province, 60090
About this study
Official title: Is Isthmosel Becoming History? The Effect of Three Different Uterotomy Closure
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).
- Conditions
- Isthmocele
- Being tested
- Baseball Suturing Technique, Single-Layer Locked Continuous Suturing Technique, Single-Layer Unlocked Continuous Suturing Technique
- Keywords
- niche, baseball suturing, uterotomy, caesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseball Suturing TechniqueProcedure or surgery
(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 TechniqueProcedure or surgery
(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 TechniqueProcedure or surgery
(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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Baseball Suturing Technique; Procedure: Single-Layer Locked Continuous Suturing Technique; Procedure: Single-Layer Unlocked Continuous Suturing Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isthmocele was be evaluated
The presence and anatomical location of isthmocele were be evaluated by ultrasonography.
Measured: Three months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 May 2022
- Primary completion30 Oct 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IsthmoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Neset Gumusburun, M.D., Principal investigator, Gazıosmanpasa Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761495
- Sponsor's protocol ID
- MLP Tokat
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Isthmosel Becoming History? The Effect of Three Different Uterotomy Closure
- ClinicalTrials.gov ID
- NCT06761495
- Acronym / sponsor ID
- MLP Tokat
- Conditions
- Isthmocele
- Keywords
- niche, baseball suturing, uterotomy, caesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Isthmosel (caesarean scar defect ) | Active comparator | Procedure: Baseball Suturing Technique, Procedure: Single-Layer Locked Continuous Suturing Technique, Procedure: Single-Layer Unlocked Continuous Suturing TechniqueIsthmosel 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. |
| Residual myometrial thickness | Active comparator | Procedure: Baseball Suturing Technique, Procedure: Single-Layer Locked Continuous Suturing Technique, Procedure: Single-Layer Unlocked Continuous Suturing TechniqueThree months after the operation, residual myometrial thickness localization was evaluated by ultrasonography. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant women undergoing C/S for the first time
- 37 weeks < gestation (term pregnancies)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Isthmosel (caesarean scar defect ), Residual myometrial thickness |
| 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 | Procedure or surgery | Isthmosel (caesarean scar defect ), Residual myometrial thickness |
| 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 | Procedure or surgery | Isthmosel (caesarean scar defect ), Residual myometrial thickness |
Primary outcome
Isthmocele was be evaluated
Time frame: Three months postoperatively
The presence and anatomical location of isthmocele were be evaluated by ultrasonography.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: Yes
Related trials for Isthmocele
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Impact of Vertical vs. Transverse Closure on Outcomes of Laparoscopic Correction of Isthmocele
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neset Gumusburun, M.D. principal investigator
Gazıosmanpasa Unıversity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseball Suturing Technique, Single-Layer Locked Continuous Suturing Technique and Single-Layer Unlocked Continuous Suturing Technique in people with Isthmocele, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isthmocele was be evaluated (time frame: Three months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.