Cesarean Scar Defect (Isthmococele)NCT07841028
Incision-Parallel Double-Layer Non-Locking Versus Single-Layer Locked Uterine Closure After Primary Caesarean Delivery: A Randomized Controlled Trial
A study testing Single-Layer Locked Uterine Closure and Double-Layer Incision-Parallel Nonlocking Uterine Closure in people with Cesarean Scar Defect (Isthmococele), run by Onur Karaaslan at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial was conducted to compare two uterine closure techniques in women undergoing primary cesarean delivery. The study evaluated whether the technique used to close the uterine incision affects the development and characteristics of cesarean scar defects (CSD). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Scar Defect (Isthmococele)
- What is being tested?
- Single-Layer Locked Uterine Closure and Double-Layer Incision-Parallel Nonlocking Uterine Closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jun 2024to 15 Feb 2025
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-45 years Undergoing first cesarean delivery Early-term, term, or post-term pregnancy Elective or emergency indication for cesarean delivery Provided written informed consent
Who cannot join
- Previous cesarean delivery Congenital uterine anomaly Chronic anemia Uncontrolled gestational or pregestational diabetes mellitus Uncontrolled hypertension Severe preeclampsia Body mass index >30 kg/m² Active labor lasting >5 hours Cervical dilatation >5 cm at cesarean delivery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yuzuncu Yil University Faculty of Medicine
Van, Van, 65000
About this study
This randomized controlled trial was conducted to compare two uterine closure techniques in women undergoing primary cesarean delivery. The study evaluated whether the technique used to close the uterine incision affects the development and characteristics of cesarean scar defects (CSD).
Participants were randomly assigned in a 1:1 ratio to either a conventional single-layer locked continuous uterine closure technique or a double-layer, incision-parallel, nonlocking continuous closure technique. Cesarean scar healing was evaluated at least three months after delivery using transvaginal ultrasonography. The primary outcome was the presence of a cesarean scar defect. Additional ultrasound measurements were used to evaluate the morphology of the cesarean scar and residual myometrial thickness.
- Conditions
- Cesarean Scar Defect (Isthmococele)
- Being tested
- Single-Layer Locked Uterine Closure, Double-Layer Incision-Parallel Nonlocking Uterine Closure
- Keywords
- Cesarean scar defect, Cesarean scar niche, Residual myometrial thickness, Uterine closure, Locked suture, Nonlocking suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-Layer Locked Uterine ClosureProcedure or surgery
Uterine closure was performed using a single-layer locked continuous suturing technique after cesarean delivery.
Double-Layer Incision-Parallel Nonlocking Uterine ClosureProcedure or surgery
Uterine closure was performed using a double-layer, incision-parallel, continuous nonlocking suturing technique. Primary corner sutures were placed at both ends of the uterine incision. In the first layer, the lower-segment myometrium was approximated with full-thickness nonlocking sutures placed parallel to the incision, with corresponding bites taken from the upper segment at the same level. The second layer consisted of continuous nonlocking approximation of the serosal-subserosal tissue.
| Study group | Role | What they receive |
|---|---|---|
| Single-Layer Locked Uterine Closure | Active comparator | Participants underwent uterine incision closure using a single-layer locked continuous suturing technique. Receives: Procedure: Single-Layer Locked Uterine Closure |
| Double-Layer Nonlocking Uterine Closure | Experimental | Participants underwent uterine incision closure using a double-layer, incision-parallel, nonlocking continuous suturing technique. Receives: Procedure: Double-Layer Incision-Parallel Nonlocking Uterine Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Cesarean Scar Defect
Cesarean scar defect (CSD) was assessed by transvaginal ultrasonography and defined as a visible hypoechoic indentation at the site of the cesarean scar with a depth of at least 2 mm.
Measured: At least 3 months after cesarean delivery
Secondary outcomes (2)
Cesarean Scar Morphometric Measurements
Cesarean scar morphology was assessed by transvaginal ultrasonography. Measurements included scar indentation depth and length, residual myometrial thickness (RMT), adjacent myometrial thickness (AMT), uterovesical fold distance, vesicovaginal fold distance, and the distance between the scar indentation and the external cervical os. Measurements were expressed in millimeters. Scar indentation morphology was also recorded. When no indentation was visible, indentation depth and length were recorded as 0 mm, and external os distance was considered not applicable.
Measured: At least 3 months after cesarean delivery
Perioperative Hemoglobin Change
Hemoglobin levels were measured preoperatively and on postoperative day 1. Hemoglobin reduction was calculated as the preoperative hemoglobin value minus the postoperative day-1 value and was expressed in g/dL.
Measured: From preoperative assessment to postoperative day 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start17 Jun 2024
- Primary completion15 Feb 2025
- Study completion15 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Scar Defect (Isthmococele)Studies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onur Karaaslan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Onur Karaaslan, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841028
- Sponsor's protocol ID
- Karar No: 01
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be publicly shared due to participant confidentiality and ethical considerations.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incision-Parallel Double-Layer Non-Locking Versus Single-Layer Locked Uterine Closure After Primary Caesarean Delivery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07841028
- Acronym / sponsor ID
- Karar No: 01
- Conditions
- Cesarean Scar Defect (Isthmococele)
- Keywords
- Cesarean scar defect, Cesarean scar niche, Residual myometrial thickness, Uterine closure, Locked suture, Nonlocking suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Onur KaraaslanUniversity, hospital or other
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 15 Feb 2025 (actual)
- First posted
- 25 Sep 2026 (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.
This randomized controlled trial was conducted to compare two uterine closure techniques in women undergoing primary cesarean delivery. The study evaluated whether the technique used to close the uterine incision affects the development and characteristics of cesarean scar defects (CSD).
Participants were randomly assigned in a 1:1 ratio to either a conventional single-layer locked continuous uterine closure technique or a double-layer, incision-parallel, nonlocking continuous closure technique. Cesarean scar healing was evaluated at least three months after delivery using transvaginal ultrasonography. The primary outcome was the presence of a cesarean scar defect. Additional ultrasound measurements were used to evaluate the morphology of the cesarean scar and residual myometrial thickness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-Layer Locked Uterine Closure | Active comparator | Procedure: Single-Layer Locked Uterine ClosureParticipants underwent uterine incision closure using a single-layer locked continuous suturing technique. |
| Double-Layer Nonlocking Uterine Closure | Experimental | Procedure: Double-Layer Incision-Parallel Nonlocking Uterine ClosureParticipants underwent uterine incision closure using a double-layer, incision-parallel, nonlocking continuous suturing technique. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 18-45 years Undergoing first cesarean delivery Early-term, term, or post-term pregnancy Elective or emergency indication for cesarean delivery Provided written informed consent
Key exclusion criteria (1 listed)
- Previous cesarean delivery Congenital uterine anomaly Chronic anemia Uncontrolled gestational or pregestational diabetes mellitus Uncontrolled hypertension Severe preeclampsia Body mass index >30 kg/m² Active labor lasting >5 hours Cervical dilatation >5 cm at cesarean delivery
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 |
|---|---|---|
| Single-Layer Locked Uterine ClosureUterine closure was performed using a single-layer locked continuous suturing technique after cesarean delivery. | Procedure or surgery | Single-Layer Locked Uterine Closure |
| Double-Layer Incision-Parallel Nonlocking Uterine ClosureUterine closure was performed using a double-layer, incision-parallel, continuous nonlocking suturing technique. Primary corner sutures were placed at both ends of the uterine incision. In the first layer, the lower-segment myometrium was approximated with full-thickness nonlocking sutures placed parallel to the incision, with corresponding bites taken from the upper segment at the same level. The second layer consisted of continuous nonlocking approximation of the serosal-subserosal tissue. | Procedure or surgery | Double-Layer Nonlocking Uterine Closure |
Primary outcome
Incidence of Cesarean Scar Defect
Time frame: At least 3 months after cesarean delivery
Cesarean scar defect (CSD) was assessed by transvaginal ultrasonography and defined as a visible hypoechoic indentation at the site of the cesarean scar with a depth of at least 2 mm.
2 secondary outcomes
Cesarean Scar Morphometric Measurements
Time frame: At least 3 months after cesarean delivery
Perioperative Hemoglobin Change
Time frame: From preoperative assessment to postoperative day 1.
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 25 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to participant confidentiality and ethical considerations.
Related trials for Cesarean Scar Defect (Isthmococele)
Recruiting
Single- vs Double-Layer Cesarean Scar Repair and Myometrial Thickness
Caesarean Section, Cesarean Scar Closure
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-Layer Locked Uterine Closure and Double-Layer Incision-Parallel Nonlocking Uterine Closure in people with Cesarean Scar Defect (Isthmococele), run by Onur Karaaslan 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 1 inclusion and 1 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 25 Sep 2026. 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?
Incidence of Cesarean Scar Defect (time frame: At least 3 months after cesarean delivery). 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 25 Sep 2026.