Caesarean Scar NicheNCT06695793
Niche Investigated: Closure of Hysterotomy & Evaluation of 3 Suturing Techniques (Running, Interrupted, and Locked)
A study testing Interrupted Sutures, Locked Sutures and Running Continuous Sutures in people with Caesarean Scar Niche, run by Cairo University at 5 sites in Egypt.
Trial summary
This study aims to explore the impact of three different suturing techniques (Running, Interrupted \& Locked) that used to close the uterine incision at the cesarean section on the formation of a cesarean scar niche Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Caesarean Scar Niche
- What is being tested?
- Interrupted Sutures, Locked Sutures and Running Continuous Sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 5 sitesEgypt
- Study dates
- 1 Nov 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with a singleton pregnancy scheduled for elective cesarean section
- Gestational age at the time of cesarean section between 38 and 40 weeks.
- Willingness to participate in the study and provide informed consent
- Age between 18 and 35 years old.
- BMI <30
Who cannot join
- Known uterine anomalies or previous uterine surgery (e.g, myomectomy, uterine septum resection)
- Pre-existing medical conditions contraindicating cesarean delivery or affecting uterine healing (e.g., Anemia, Diabetes)
- Current smokers.
- Non-cephalic presentation of the fetus.
- Low-lying anterior wall placenta and placenta previa.
- Inability to provide informed consent (e.g., cognitive impairment, language barrier)
- Any condition deemed by the attending physician to pose a risk to the participant or compromise the study's integrity, for example, Patients who will require excessive suturing for further hemostasis or those who require ligation of one or both uterine arteries
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Egypt5 sites, 5 recruiting
- Recruiting
Cairo University
Cairo
amr essam, +201004365349, amro_394@hotmail.com
- Recruiting
Cairo University
Cairo
Abdalla Mousa, +201277664430, Dr_abdallamousa@yahoo.com
- Recruiting
Cairo University
Cairo
Moutaz ElSherbiny, +20100158300, mizoelsherbini@yahoo.com
- Recruiting
Cairo University
Cairo
Mahmoud Soliman, +201222251268, dr_mahmoudsoliman@yahoo.com
- Recruiting
Cairo University
Cairo
Ibrahim Fawzy, +201062641235, ibrahimfawzyibrahimfawzy@gmail.com
About this study
This study aims to explore the impact of three different suturing techniques (Running, Interrupted \& Locked) that used to close the uterine incision at the cesarean section on the formation of a cesarean scar niche
- Conditions
- Caesarean Scar Niche
- Being tested
- Interrupted Sutures, Locked Sutures, Running Continuous Sutures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interrupted SuturesProcedure or surgery
The first layer of uterine incision will be closed using individual, separate sutures placed at regular intervals along the incision line. Each suture will be tied independently, ensuring adequate apposition of uterine tissue, followed by a second layer of running continuous sutures.
Locked SuturesProcedure or surgery
The first layer of uterine incision will be closed using continuous sutures placed along the uterine incision, incorporating a locking technique at specified intervals to prevent unraveling. The knots will be securely tied to maintain tissue approximation, followed by a second layer of running continuous sutures.
Running Continuous SuturesBiological
Double layer closure of uterine incision using running continuous suture used to close the uterine incision without interruption, providing seamless tissue approximation throughout the incision length.
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Experimental | Interrupted Sutures: The first layer of the uterine incision will be closed using individual, separate sutures placed at regular intervals along the incision line. Each suture will be tied independently, ensuring adequate apposition of uterine tissue, followed by a second layer of running continuous sutures. Receives: Procedure: Interrupted Sutures |
| Group (B) | Experimental | Locked Sutures: The first layer of the uterine incision will be closed using continuous sutures placed along the uterine incision, incorporating a locking technique at specified intervals to prevent unraveling. The knots will be securely tied to maintain tissue approximation, followed by a second layer of running continuous sutures. Receives: Procedure: Locked Sutures |
| Group (C) | Experimental | Running Continuous Sutures: Double layer closure of uterine incision using running continuous suture used to close the uterine incision without interruption, providing seamless tissue approximation throughout the incision length. Receives: Biological: Running Continuous Sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of caesarean scar niche and its dimensions.
Follow-up visits will be scheduled at 6-12 weeks post-cesarean section to assess caesarean section niche formation using trans-vaginal ultrasound using Samsung Elite with endovaginal probe of frequency 6 - 12 MHz. Trained sonographers, blinded to the participants' suturing group, will perform the ultrasound examinations to evaluate caesarean section niche presence and its dimensions.
Measured: 6-12 weeks post-cesarean section
Secondary outcomes (2)
Operative time
Measured: during operation
Estimate blood loss
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start1 Nov 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caesarean Scar NicheStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdalla Mousa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06695793
- Sponsor's protocol ID
- MD-308-2024
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Niche Investigated: Closure of Hysterotomy & Evaluation of 3 Suturing Techniques (Running, Interrupted, and Locked)
- ClinicalTrials.gov ID
- NCT06695793
- Acronym / sponsor ID
- MD-308-2024
- Conditions
- Caesarean Scar Niche
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 19 Nov 2024 (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 aims to explore the impact of three different suturing techniques (Running, Interrupted \& Locked) that used to close the uterine incision at the cesarean section on the formation of a cesarean scar niche
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Experimental | Procedure: Interrupted SuturesInterrupted Sutures: The first layer of the uterine incision will be closed using individual, separate sutures placed at regular intervals along the incision line. Each suture will be tied independently, ensuring adequate apposition of uterine tissue, followed by a second layer of running continuous sutures. |
| Group (B) | Experimental | Procedure: Locked SuturesLocked Sutures: The first layer of the uterine incision will be closed using continuous sutures placed along the uterine incision, incorporating a locking technique at specified intervals to prevent unraveling. The knots will be securely tied to maintain tissue approximation, followed by a second layer of running continuous sutures. |
| Group (C) | Experimental | Biological: Running Continuous SuturesRunning Continuous Sutures: Double layer closure of uterine incision using running continuous suture used to close the uterine incision without interruption, providing seamless tissue approximation throughout the incision length. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women with a singleton pregnancy scheduled for elective cesarean section
- Gestational age at the time of cesarean section between 38 and 40 weeks.
- Willingness to participate in the study and provide informed consent
- Age between 18 and 35 years old.
- BMI <30
Key exclusion criteria (7 listed)
- Known uterine anomalies or previous uterine surgery (e.g, myomectomy, uterine septum resection)
- Pre-existing medical conditions contraindicating cesarean delivery or affecting uterine healing (e.g., Anemia, Diabetes)
- Current smokers.
- Non-cephalic presentation of the fetus.
- Low-lying anterior wall placenta and placenta previa.
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 |
|---|---|---|
| Interrupted SuturesThe first layer of uterine incision will be closed using individual, separate sutures placed at regular intervals along the incision line. Each suture will be tied independently, ensuring adequate apposition of uterine tissue, followed by a second layer of running continuous sutures. | Procedure or surgery | Group (A) |
| Locked SuturesThe first layer of uterine incision will be closed using continuous sutures placed along the uterine incision, incorporating a locking technique at specified intervals to prevent unraveling. The knots will be securely tied to maintain tissue approximation, followed by a second layer of running continuous sutures. | Procedure or surgery | Group (B) |
| Running Continuous SuturesDouble layer closure of uterine incision using running continuous suture used to close the uterine incision without interruption, providing seamless tissue approximation throughout the incision length. | Biological | Group (C) |
Primary outcome
Presence of caesarean scar niche and its dimensions.
Time frame: 6-12 weeks post-cesarean section
Follow-up visits will be scheduled at 6-12 weeks post-cesarean section to assess caesarean section niche formation using trans-vaginal ultrasound using Samsung Elite with endovaginal probe of frequency 6 - 12 MHz. Trained sonographers, blinded to the participants' suturing group, will perform the ultrasound examinations to evaluate caesarean section niche presence and its dimensions.
2 secondary outcomes
Operative time
Time frame: during operation
Estimate blood loss
Time frame: during operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
Related trials for Caesarean Scar Niche
Not yet recruiting
Effectiveness of Transvaginal Niche Resection Versus Expectant Management in Patients with Secondary Infertility and a Large Uterine Caesarean Scar Defect
Caesarean Scar Defect
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interrupted Sutures, Locked Sutures and Running Continuous Sutures in people with Caesarean Scar Niche, run by Cairo University at 5 sites 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 5 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: looking for participants now, as of the sponsor's last update on 19 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abdalla Moussa (+20127664430, Dr_abdallamousa@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of caesarean scar niche and its dimensions. (time frame: 6-12 weeks post-cesarean section). 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 19 Nov 2024.