Cesarean Section ComplicationsNCT07101952
Suture Material and C-Section Scar Niches: A Comparative Study
A study testing Braded Suture material and Multifilament vicryl suture material in people with Cesarean Section Complications, run by Benha University at 1 site in Egypt.
Trial summary
Defective healing of the uterine wound after a Cesarean section (CS) can lead to the formation of a CS niche (CSN). The specific technique used for closure and the type of suture material chosen are often overlooked factors that might contribute to the development of these niches. Read more about this study
- Who is it for?
- Ages 22 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Braded Suture material and Multifilament vicryl suture material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jul 2024to 25 Oct 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 22 to 47 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients planned for CS delivery either on emergency or elective bases for singleton fetus in cephalic presentation;
- Patients were free of exclusion criteria;
- Patients who signed the written consent to participate in the study and attend the postpartum follow-up for three months.
Who cannot join
- Patients who had multiple pregnancy;
- Patients who had fetus in abnormal lie or presentation;
- Patients who had previous repair of CSN;
- Patients with uncontrolled DM or hypertension;
- Patients who had maintained on immunosuppressive therapies, had autoimmune disorders;
- Patients who refused to sign the written consent were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Suture Material Used for Cesarean Section Hysterotomy Closure on the Frequency of Scare Niche Formation
Defective healing of the uterine wound after a Cesarean section (CS) can lead to the formation of a CS niche (CSN). The specific technique used for closure and the type of suture material chosen are often overlooked factors that might contribute to the development of these niches. This study aimed to compare how frequently CSNs occur when the CS hysterotomy is closed using barbed suture material versus conventional vicryl suture material, with assessments primarily done via transvaginal ultrasound (TVS).
The methodology involved closing the CS hysterotomy with a double-layer technique using unlocked continuous running sutures, where the first layer included the decidua and was overlapped by the second. Researchers evaluated several aspects, including the duration and feasibility of the hysterotomy closure, the grade of postoperative pain, and the length of hospital stay. Transvaginal ultrasounds were conducted monthly for three months post-operatively to monitor for CSN development and to gather descriptive measurements of any niches found. The absence of a CSN was considered an indicator of surgical success.
- Conditions
- Cesarean Section Complications
- Being tested
- Braded Suture material, Multifilament vicryl suture material
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Braded Suture materialOther
Also called Absorbable synthetic monofilament polydioxanone with bars
The Cesarean section hysterotomy was closed using a double-layer technique involving unlocked continuous running sutures. The first layer incorporated the decidua, which was then overlapped by the second. The suture material used for this closure was barbed suture; which is absorbable synthetic monofilament polydioxanone with bars.
Multifilament vicryl suture materialOther
The Cesarean section hysterotomy was closed using a double-layer technique involving unlocked continuous running sutures. The first layer incorporated the decidua, which was then overlapped by the second. The suture material used for this closure was barbed suture; which is absorbable synthetic monofilament polydioxanone with bars.
| Study group | Role | What they receive |
|---|---|---|
| Vicryl group | Active comparator | In these patients, the Cesarean section hysterotomy was closed using a double-layer technique involving unlocked continuous running sutures. The first layer incorporated the decidua, which was then overlapped by the second. The suture material used for this closure was conventional multifilament Vicryl. Receives: Other: Multifilament vicryl suture material |
| Barbed absorbable synthetic monofilament group | Active comparator | In these patients, the Cesarean section hysterotomy was closed using a double-layer technique involving unlocked continuous running sutures. The first layer incorporated the decidua, which was then overlapped by the second. The suture material used for this closure was barbed suture; which is absorbable synthetic monofilament polydioxanone with bars. Receives: Other: Braded Suture material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Success Rate in Relation to Suture Material
The comparison of the overall surgical success rate, defined by the absence of a Cesarean section niche (CSN), between groups using different suture materials, alongside the quantitative differences in descriptive metrics of any formed CSNs.
Measured: 3.5 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start12 Jul 2024
- Primary completion15 Sep 2024
- Study completion25 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Sakr, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101952
- Sponsor's protocol ID
- RC 2-11-2024
- Status last verified
- Jul 2025
- First submitted
- 13 Jul 2025
- Last updated
- 3 Aug 2025
- 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 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Suture Material Used for Cesarean Section Hysterotomy Closure on the Frequency of Scare Niche Formation
- ClinicalTrials.gov ID
- NCT07101952
- Acronym / sponsor ID
- RC 2-11-2024
- Conditions
- Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 25 Oct 2024 (actual)
- First posted
- 3 Aug 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.
Defective healing of the uterine wound after a Cesarean section (CS) can lead to the formation of a CS niche (CSN). The specific technique used for closure and the type of suture material chosen are often overlooked factors that might contribute to the development of these niches. This study aimed to compare how frequently CSNs occur when the CS hysterotomy is closed using barbed suture material versus conventional vicryl suture material, with assessments primarily done via transvaginal ultrasound (TVS).
The methodology involved closing the CS hysterotomy with a double-layer technique using unlocked continuous running sutures, where the first layer included the decidua and was overlapped by the second. Researchers evaluated several aspects, including the duration and feasibility of the hysterotomy closure, the grade of postoperative pain, and the length of hospital stay. Transvaginal ultrasounds were conducted monthly for three months post-operatively to monitor for CSN development and to gather descriptive measurements of any niches found. The absence of a CSN was considered an indicator of surgical success.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vicryl group | Active comparator | Other: Multifilament vicryl suture materialIn these patients, the Cesarean section hysterotomy was closed using a double-layer technique involving unlocked continuous running sutures. The first layer incorporated the decidua, which was then overlapped by the second. The suture material used for this closure was conventional multifilament Vicryl. |
| Barbed absorbable synthetic monofilament group | Active comparator | Other: Braded Suture materialIn these patients, the Cesarean section hysterotomy was closed using a double-layer technique involving unlocked continuous running sutures. The first layer incorporated the decidua, which was then overlapped by the second. The suture material used for this closure was barbed suture; which is absorbable synthetic monofilament polydioxanone with bars. |
Who may qualify
- Ages
- 22 to 47 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients planned for CS delivery either on emergency or elective bases for singleton fetus in cephalic presentation;
- Patients were free of exclusion criteria;
- Patients who signed the written consent to participate in the study and attend the postpartum follow-up for three months.
Key exclusion criteria (6 listed)
- Patients who had multiple pregnancy;
- Patients who had fetus in abnormal lie or presentation;
- Patients who had previous repair of CSN;
- Patients with uncontrolled DM or hypertension;
- Patients who had maintained on immunosuppressive therapies, had autoimmune disorders;
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 |
|---|---|---|
| Braded Suture materialAlso: Absorbable synthetic monofilament polydioxanone with barsThe Cesarean section hysterotomy was closed using a double-layer technique involving unlocked continuous running sutures. The first layer incorporated the decidua, which was then overlapped by the second. The suture material used for this closure was barbed suture; which is absorbable synthetic monofilament polydioxanone with bars. | Other | Barbed absorbable synthetic monofilament group |
| Multifilament vicryl suture materialThe Cesarean section hysterotomy was closed using a double-layer technique involving unlocked continuous running sutures. The first layer incorporated the decidua, which was then overlapped by the second. The suture material used for this closure was barbed suture; which is absorbable synthetic monofilament polydioxanone with bars. | Other | Vicryl group |
Primary outcome
Surgical Success Rate in Relation to Suture Material
Time frame: 3.5 Months
The comparison of the overall surgical success rate, defined by the absence of a Cesarean section niche (CSN), between groups using different suture materials, alongside the quantitative differences in descriptive metrics of any formed CSNs.
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 3 Aug 2025.
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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 Braded Suture material and Multifilament vicryl suture material in people with Cesarean Section Complications, run by Benha 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 3 inclusion and 6 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 3 Aug 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?
Surgical Success Rate in Relation to Suture Material (time frame: 3.5 Months). 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 3 Aug 2025.