Niche Investigated: Closure of Hysterotomy & Evaluation of 3 Suturing Techniques (Running, Interrupted, and Locked)
NCT ID: NCT06695793
Last Updated: 2024-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
225 participants
INTERVENTIONAL
2024-11-01
2026-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Suture Material and C-Section Scar Niches: A Comparative Study
NCT07101952
Comparison the Effect of Uterine Closure Technique Difference on Uterine Niche After Caesarean Delivery.
NCT04799457
Surgical Incision Closure Method to Prevent Niche Formation After Cesarean Section- Randomized Controlled Trial
NCT04766073
UTERUS CLOSURE TECHNIQUES and Uterine Niche Formation
NCT05517018
Comparative Analysis of Subcuticular Suture Materials in Cesarean Section
NCT06543329
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group (A)
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.
Interrupted Sutures
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.
Group (B)
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.
Locked Sutures
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.
Group (C)
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Interrupted Sutures
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 Sutures
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 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Gestational age at the time of cesarean section between 38 and 40 weeks.
3. Willingness to participate in the study and provide informed consent
4. Age between 18 and 35 years old.
5. BMI \<30
Exclusion Criteria
2. Pre-existing medical conditions contraindicating cesarean delivery or affecting uterine healing (e.g., Anemia, Diabetes)
3. Current smokers.
4. Non-cephalic presentation of the fetus.
5. Low-lying anterior wall placenta and placenta previa.
6. Inability to provide informed consent (e.g., cognitive impairment, language barrier)
7. 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
18 Years
35 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cairo University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Abdalla Mousa
Lecturer of obgyn Cairo university
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cairo University
Cairo, , Egypt
Cairo University
Cairo, , Egypt
Cairo University
Cairo, , Egypt
Cairo University
Cairo, , Egypt
Cairo University
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MD-308-2024
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.