Cesarean Section, RepeatedNCT03644433
Impact of Uterine Closure Techniques on the Cesarean Scar Thickness After Repeated Cesarean Section
A study testing Single layer closure and Double layer closure after resection uterine scar in people with Cesarean Section, Repeated and Cesarean, Uterine Scar Thickness, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
We compares two techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. We will evaluate myometrial thickness by transvaginal ultrasound six months after cesarean. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section, Repeated, Cesarean, Uterine Scar Thickness, Cesarean, Residual Myometrial Thickness
- What is being tested?
- Single layer closure and Double layer closure after resection uterine scar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Aug 2018to 30 Apr 2019
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- previous two or three cesarean
- gestational weeks >=36 weeks
Who cannot join
- risk of obstetric haemorrhage
- suspicion or diagnosis placenta previa or accrete syndrome
- chorioamnionitis
- uterine myoma in the anterior uterine segment
- hysterotomy other than lower segment uterine incision at previous cesarean
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Atatürk Üniversitesi araştırma Hastanesi
Erzurum, 25240
Raşit Özler, Md
About this study
Official title: Impact of Single Layer Versus Double Layer Uterine Closure on the Cesarean Scar Healing
We compares two techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. We will evaluate myometrial thickness by transvaginal ultrasound six months after cesarean.
- Conditions
- Cesarean Section, Repeated, Cesarean, Uterine Scar Thickness, Cesarean, Residual Myometrial Thickness, Cesarean Section Complications, Cesarean Section; Complications, Wound, Dehiscence
- Being tested
- Single layer closure, Double layer closure after resection uterine scar
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single layer closureProcedure or surgery
Uterine incision will be approximated with continuous unlocked suture avoiding the inclusion endometrium and without trimming incision edges.
Double layer closure after resection uterine scarProcedure or surgery
Uterine incision will be trimmed and old scar tissue will be removed. Then first, endometrium will be approximated by continuous unlocked suture mimicking subcuticular suture avoiding the inclusion of endometrium and second, upper part of myometrium will be approximated by a continuous unlocked suture.
| Study group | Role | What they receive |
|---|---|---|
| Single layer | Placebo comparator | Single layer closure Receives: Procedure: Single layer closure |
| Double layer with resection | Active comparator | Double layer closure after resection uterine scar Receives: Procedure: Double layer closure after resection uterine scar |
What is being measured
The primary outcome is the main question the study is designed to answer.
residual myometrial thickness
Myometrial thickness at the uterine scar by transvaginal ultrasound
Measured: 6 months after cesarean
Secondary outcomes (10)
residual myometrial thickness
Myometrial thickness at the uterine scar by transvaginal ultrasound
Measured: 6 weeks after cesarean
Healing ratio
residual myometrial thickness * 100 /total myometrial thickness above uterine scar
Measured: 6 months after cesarean
Healing ratio
residual myometrial thickness * 100 /total myometrial thickness above uterine scar
Measured: 6 weeks after cesarean
Existence of cesarean scar defect
The presence or absence of a cesarean scar defect that was defined as any unechogenic area visualised by transvaginal ultrasound at the site of the cesarean scar with a depth of at least 1 mm.
Measured: 6 months after cesarean
Existence of cesarean scar defect
The presence or absence of a cesarean scar defect that was defined as any unechogenic area visualised by transvaginal ultrasound at the site of the cesarean scar with a depth of at least 1 mm.
Measured: 6 weeks after cesarean
Operation time
skin-to-skin operation time
Measured: 10 minute after cesarean completed
Change in hemoglobin
Difference in haemoglobin measured preoperatively and postoperatively 48 hours
Measured: 48 hours after cesarean
Blood product transfusion
unite number of transfused packed erythrocyte
Measured: One week after cesarean
Maternal infectious morbidity
prevalence of postpartum endometritis, skin wound dehiscence and post operative fever.
Measured: six weeks after cesarean
Length of hospitalization
Duration in days
Measured: One month after cesarean
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start23 Aug 2018
- Primary completion30 Apr 2019 (estimated)
- Study completion30 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section, RepeatedStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragıp Atakan Al, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644433
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/4
- Status last verified
- Aug 2018
- First submitted
- 6 Jul 2018
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ozler MR, Al RA. A prospective comparative study of single-layer versus double-layer uterine closure techniques on cesarean scar formation. BMC Pregnancy Childbirth. 2025 Aug 20;25(1):868. doi: 10.1186/s12884-025-08010-3.
PubMed 40836292
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Single Layer Versus Double Layer Uterine Closure on the Cesarean Scar Healing
- ClinicalTrials.gov ID
- NCT03644433
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/4
- Conditions
- Cesarean Section, Repeated, Cesarean, Uterine Scar Thickness, Cesarean, Residual Myometrial Thickness, Cesarean Section Complications, Cesarean Section; Complications, Wound, Dehiscence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 30 Apr 2019 (estimated)
- Study completion
- 30 Apr 2019 (estimated)
- First posted
- 23 Aug 2018 (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.
We compares two techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. We will evaluate myometrial thickness by transvaginal ultrasound six months after cesarean.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single layer | Placebo comparator | Procedure: Single layer closureSingle layer closure |
| Double layer with resection | Active comparator | Procedure: Double layer closure after resection uterine scarDouble layer closure after resection uterine scar |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- previous two or three cesarean
- gestational weeks >=36 weeks
Key exclusion criteria (5 listed)
- risk of obstetric haemorrhage
- suspicion or diagnosis placenta previa or accrete syndrome
- chorioamnionitis
- uterine myoma in the anterior uterine segment
- hysterotomy other than lower segment uterine incision at previous cesarean
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 closureUterine incision will be approximated with continuous unlocked suture avoiding the inclusion endometrium and without trimming incision edges. | Procedure or surgery | Single layer |
| Double layer closure after resection uterine scarUterine incision will be trimmed and old scar tissue will be removed. Then first, endometrium will be approximated by continuous unlocked suture mimicking subcuticular suture avoiding the inclusion of endometrium and second, upper part of myometrium will be approximated by a continuous unlocked suture. | Procedure or surgery | Double layer with resection |
Primary outcome
residual myometrial thickness
Time frame: 6 months after cesarean
Myometrial thickness at the uterine scar by transvaginal ultrasound
10 secondary outcomes
residual myometrial thickness
Time frame: 6 weeks after cesarean
Healing ratio
Time frame: 6 months after cesarean
Healing ratio
Time frame: 6 weeks after cesarean
Existence of cesarean scar defect
Time frame: 6 months after cesarean
Existence of cesarean scar defect
Time frame: 6 weeks after cesarean
Operation time
Time frame: 10 minute after cesarean completed
Change in hemoglobin
Time frame: 48 hours after cesarean
Blood product transfusion
Time frame: One week after cesarean
Maternal infectious morbidity
Time frame: six weeks after cesarean
Length of hospitalization
Time frame: One month after cesarean
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Derived from this study: PubMed 40836292Ozler MR, Al RA. A prospective comparative study of single-layer versus double-layer uterine closure techniques on cesarean scar formation. BMC Pregnancy Childbirth. 2025 Aug 20;25(1):868. doi: 10.1186/s12884-025-08010-3.
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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.
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 closure and Double layer closure after resection uterine scar in people with Cesarean Section, Repeated and Cesarean, Uterine Scar Thickness, run by Ataturk 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 5 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: status not confirmed, as of the sponsor's last update on 24 Aug 2018. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raşit Özler, Md (00905465252595, m.rasitozler@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
residual myometrial thickness (time frame: 6 months after cesarean). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03644433, which also lists 1 linked publication.
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 24 Aug 2018.