Cesarean Section, RepeatedNCT03915847
Evaluation of Cesarean Scar After Three Different Uterine Closure Technis
A study testing Single layer closure, Double layer closure and Doble layer closure with trimming in people with Cesarean Section, Repeated and Cesarean, Uterine Scar Thickness, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The study compares three techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. Cesarean scar will be evaluated 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, Double layer closure and Doble layer closure with trimming
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Apr 2019to 16 Apr 2020
- 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.
About this study
Official title: Evaluation of Cesarean Scar After Three Different Uterine Closure Technis: A Randomised Trial
The study compares three techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. Cesarean scar will be evaluated by transvaginal ultrasound six months after cesarean.
- Conditions
- Cesarean Section, Repeated, Cesarean, Uterine Scar Thickness, Cesarean, Residual Myometrial Thickness
- Being tested
- Single layer closure, Double layer closure, Doble layer closure with trimming
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, including a narrow band of the endometrial layer, without trimming incision edges.
Double layer closureProcedure or surgery
The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.
Doble layer closure with trimmingProcedure or surgery
Uterine incision will be trimmed and old scar tissue will be removed. The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.
| Study group | Role | What they receive |
|---|---|---|
| Single layer closure | Active comparator | Not described Receives: Procedure: Single layer closure |
| Double layer closure | Active comparator | Not described Receives: Procedure: Double layer closure |
| Doble layer closure with trimming | Active comparator | Not described Receives: Procedure: Doble layer closure with trimming |
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 (8)
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 2 mm.
Measured: 6 months after cesarean
Width of defect
In a sagittal plane, the width at base of defect
Measured: 6 months after cesarean
Depth of defect (niche)
In a sagittal plane, the distance from the base lining of the endometrium to the apex
Measured: 6 months 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 posted16 Apr 2019
- Study start16 Apr 2019
- Primary completion16 Apr 2020
- Study completion16 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 90 participants (actual)
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
- NCT03915847
- Sponsor's protocol ID
- ATA35
- Status last verified
- May 2020
- First submitted
- 10 Apr 2019
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cesarean Scar After Three Different Uterine Closure Technis: A Randomised Trial
- ClinicalTrials.gov ID
- NCT03915847
- Acronym / sponsor ID
- ATA35
- Conditions
- Cesarean Section, Repeated, Cesarean, Uterine Scar Thickness, Cesarean, Residual Myometrial Thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 16 Apr 2020 (actual)
- Study completion
- 16 Apr 2020 (actual)
- First posted
- 16 Apr 2019 (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.
The study compares three techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. Cesarean scar will be evaluated 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Single layer closure | Active comparator | Procedure: Single layer closure |
| Double layer closure | Active comparator | Procedure: Double layer closure |
| Doble layer closure with trimming | Active comparator | Procedure: Doble layer closure with trimming |
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, including a narrow band of the endometrial layer, without trimming incision edges. | Procedure or surgery | Single layer closure |
| Double layer closureThe first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer. | Procedure or surgery | Double layer closure |
| Doble layer closure with trimmingUterine incision will be trimmed and old scar tissue will be removed. The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer. | Procedure or surgery | Doble layer closure with trimming |
Primary outcome
Residual myometrial thickness
Time frame: 6 months after cesarean
Myometrial thickness at the uterine scar by transvaginal ultrasound
8 secondary outcomes
Existence of cesarean scar defect
Time frame: 6 months after cesarean
Width of defect
Time frame: 6 months after cesarean
Depth of defect (niche)
Time frame: 6 months 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
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 11 May 2020.
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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.
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 closure, Double layer closure and Doble layer closure with trimming 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: finished, as of the sponsor's last update on 11 May 2020. 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?
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?
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 11 May 2020.