Single LayerNCT07554001
Single Layer With Unlocked Sutures Versus Double Layer Closure of Cesarean Incision and the Risk of Niche Development
A study testing Single layer unlocked sutures and Double layer unlocked sutures in people with Single Layer and Unlocked Sutures, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study aimed to compare the development of the uterine niche after single and double closure of cesarean incision. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Single Layer, Unlocked Sutures, Double Layer Closure
- What is being tested?
- Single layer unlocked sutures and Double layer unlocked sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Women who undergo first elective cesarean section (CS).
Who cannot join
- Women with a previous CS
- Inadequate possibility for counselling (e.g. indication for CS without being informed about the study previously, women in severe pain without adequate therapy
- previous major uterine surgery (e.g. laparoscopic or laparotomy fibroid resection, septum resection), Women with known causes of menstrual disorders (e.g. cervical dysplasia, communicating hydro salpinx, uterine anomaly
- Placenta increta or percreta during the current pregnancy
- ≥ Three foetuses during the current pregnancy.
- Placenta previa
- Twins
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to compare the development of the uterine niche after single and double closure of cesarean incision.
Read the detailed description
One of the most performed major surgeries worldwide is a cesarean section (CS), and CS rates are rising. These long-term complications are associated with an anatomical defect of the myometrium due to impaired healing of the incision in the uterus, a so-called uterine niche or cesarean scar defect, and with this increased rate of cesarean delivary the development of uterine niche has also increased In 50-70% of patients after cesarean section.
The classification of niche was based on the measurement of the depth, base of the isthmocele and on calculation of its triangular area. This allowed to classify the uterine niches after cesarean section according to the size of its area.
- Conditions
- Single Layer, Unlocked Sutures, Double Layer Closure, Cesarean Incision, Niche Development
- Being tested
- Single layer unlocked sutures, Double layer unlocked sutures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single layer unlocked suturesProcedure or surgery
Patients underwent uterine scar closure by single layer unlocked sutures.
Double layer unlocked suturesProcedure or surgery
Patients underwent uterine scar closure by double layer unlocked sutures.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Patients underwent uterine scar closure by single layer unlocked sutures. Receives: Procedure: Single layer unlocked sutures |
| Group II | Experimental | Patients underwent uterine scar closure by double layer unlocked sutures. Receives: Procedure: Double layer unlocked sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the presence of niche
Patient were asked about any symptoms of the niche like post menstrual spotting as brownish discharge for more than two days at the end of menses or spotting more than seven days or inter menstrual blood loss that start after the end of menses or dysmenorrhea and prolonged bleeding
Measured: 6 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 Feb 2024
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single LayerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aml Abdelfatah Mohamed Ali, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554001
- Sponsor's protocol ID
- KFSIRB200-106
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 28 Apr 2026
- 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 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Layer With Unlocked Sutures Versus Double Layer Closure of Cesarean Incision and the Risk of Niche Development
- ClinicalTrials.gov ID
- NCT07554001
- Acronym / sponsor ID
- KFSIRB200-106
- Conditions
- Single Layer, Unlocked Sutures, Double Layer Closure, Cesarean Incision, Niche Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 28 Apr 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 study aimed to compare the development of the uterine niche after single and double closure of cesarean incision.
Detailed description
One of the most performed major surgeries worldwide is a cesarean section (CS), and CS rates are rising. These long-term complications are associated with an anatomical defect of the myometrium due to impaired healing of the incision in the uterus, a so-called uterine niche or cesarean scar defect, and with this increased rate of cesarean delivary the development of uterine niche has also increased In 50-70% of patients after cesarean section.
The classification of niche was based on the measurement of the depth, base of the isthmocele and on calculation of its triangular area. This allowed to classify the uterine niches after cesarean section according to the size of its area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Procedure: Single layer unlocked suturesPatients underwent uterine scar closure by single layer unlocked sutures. |
| Group II | Experimental | Procedure: Double layer unlocked suturesPatients underwent uterine scar closure by double layer unlocked sutures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years.
- Women who undergo first elective cesarean section (CS).
Key exclusion criteria (7 listed)
- Women with a previous CS
- Inadequate possibility for counselling (e.g. indication for CS without being informed about the study previously, women in severe pain without adequate therapy
- previous major uterine surgery (e.g. laparoscopic or laparotomy fibroid resection, septum resection), Women with known causes of menstrual disorders (e.g. cervical dysplasia, communicating hydro salpinx, uterine anomaly
- Placenta increta or percreta during the current pregnancy
- ≥ Three foetuses during the current 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 |
|---|---|---|
| Single layer unlocked suturesPatients underwent uterine scar closure by single layer unlocked sutures. | Procedure or surgery | Group I |
| Double layer unlocked suturesPatients underwent uterine scar closure by double layer unlocked sutures. | Procedure or surgery | Group II |
Primary outcome
Assessment of the presence of niche
Time frame: 6 months after the procedure
Patient were asked about any symptoms of the niche like post menstrual spotting as brownish discharge for more than two days at the end of menses or spotting more than seven days or inter menstrual blood loss that start after the end of menses or dysmenorrhea and prolonged bleeding
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 28 Apr 2026.
- 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.
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 unlocked sutures and Double layer unlocked sutures in people with Single Layer and Unlocked Sutures, run by Kafrelsheikh 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 28 Apr 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 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?
Assessment of the presence of niche (time frame: 6 months after the procedure). 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 28 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.