Transvaginal UltrasoundNCT07074522
Transvaginal Ultrasound Assessment of Caesarean Section Uterine Scar Closed by Single Versus Double Layer
A study testing Single-layer closure and Double-layer closure in people with Transvaginal Ultrasound and Caesarean Section, run by Tanta University at 1 site in Egypt.
Trial summary
This study aimed to evaluate uterine scar thickness and integrity using transvaginal ultrasonography in women randomly assigned to single versus double-layer closure of the uterine incision, with a comparison between the two groups. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Transvaginal Ultrasound, Caesarean Section, Uterine Scar
- What is being tested?
- Single-layer closure and Double-layer 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 siteEgypt
- Study dates
- 1 Dec 2023to 1 Nov 2024
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age from 20 to 40 years old.
- Pregnant women underwent their first cesarean section.
Who cannot join
- Body mass index (BMI) ≥ 30 kg /m2.
- Multiple gestations.
- Uterine malformation.
- Placenta previa.
- Placenta accreta.
- Uterine or cervical fibroid.
- Any previous uterine operation or any medical disease that compromises wound healing, such as diabetes mellitus, collagen diseases, anemia, or corticosteroid therapy.
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to evaluate uterine scar thickness and integrity using transvaginal ultrasonography in women randomly assigned to single versus double-layer closure of the uterine incision, with a comparison between the two groups.
Read the detailed description
Cesarean section (CS) is one of the most commonly performed major abdominal operations in women in both high and low-income countries.
Single-layer closure using a running locking stitch is associated with decreased operative time and fewer additional haemostasis sutures. An extensive Canadian study found a fourfold increase in the risk of uterine rupture in a woman who had a single layer in their previous pregnancy.
Transvaginal ultrasound is a validated tool for evaluating uterine scar defects, commonly referred to as a niche. It is used to asses the uterine scar thickness in a women with previous cesarean delivery.
- Being tested
- Single-layer closure, Double-layer closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-layer closureProcedure or surgery
Patients who underwent single-layer closure of the transverse lower segment during cesarean section.
Double-layer closureProcedure or surgery
Patients who underwent double-layer closure of the transverse lower segment during cesarean section.
| Study group | Role | What they receive |
|---|---|---|
| Single layer group | Experimental | Patients who underwent single-layer closure of the transverse lower segment during cesarean section. Receives: Procedure: Single-layer closure |
| Double layer group | Experimental | Patients who underwent double-layer closure of the transverse lower segment during cesarean section. Receives: Procedure: Double-layer closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uterine scar thickness
Uterine scar thickness was evaluated by transvaginal ultrasound six weeks, three months, and six months postoperative.
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start1 Dec 2023
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transvaginal UltrasoundStudies of the same condition, open and under way.
- More trials run by Tanta 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Said Abd El Kareem Said Saad, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074522
- Sponsor's protocol ID
- 36264MS426/11/23
- Status last verified
- Jul 2025
- First submitted
- 10 Jul 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Ultrasound Assessment of Caesarean Section Uterine Scar Closed by Single Versus Double Layer
- ClinicalTrials.gov ID
- NCT07074522
- Acronym / sponsor ID
- 36264MS426/11/23
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 20 Jul 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.
This study aimed to evaluate uterine scar thickness and integrity using transvaginal ultrasonography in women randomly assigned to single versus double-layer closure of the uterine incision, with a comparison between the two groups.
Detailed description
Cesarean section (CS) is one of the most commonly performed major abdominal operations in women in both high and low-income countries.
Single-layer closure using a running locking stitch is associated with decreased operative time and fewer additional haemostasis sutures. An extensive Canadian study found a fourfold increase in the risk of uterine rupture in a woman who had a single layer in their previous pregnancy.
Transvaginal ultrasound is a validated tool for evaluating uterine scar defects, commonly referred to as a niche. It is used to asses the uterine scar thickness in a women with previous cesarean delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single layer group | Experimental | Procedure: Single-layer closurePatients who underwent single-layer closure of the transverse lower segment during cesarean section. |
| Double layer group | Experimental | Procedure: Double-layer closurePatients who underwent double-layer closure of the transverse lower segment during cesarean section. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age from 20 to 40 years old.
- Pregnant women underwent their first cesarean section.
Key exclusion criteria (7 listed)
- Body mass index (BMI) ≥ 30 kg /m2.
- Multiple gestations.
- Uterine malformation.
- Placenta previa.
- Placenta accreta.
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 closurePatients who underwent single-layer closure of the transverse lower segment during cesarean section. | Procedure or surgery | Single layer group |
| Double-layer closurePatients who underwent double-layer closure of the transverse lower segment during cesarean section. | Procedure or surgery | Double layer group |
Primary outcome
Uterine scar thickness
Time frame: 6 months postoperatively
Uterine scar thickness was evaluated by transvaginal ultrasound six weeks, three months, and six months postoperative.
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 20 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 and Double-layer closure in people with Transvaginal Ultrasound and Caesarean Section, run by Tanta University at 1 site in Egypt.
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 7 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 20 Jul 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 Egypt. 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?
Uterine scar thickness (time frame: 6 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 20 Jul 2025.