Cesarean Section ComplicationsPhase 2NCT07446933
Vasopressin vs. Uterine Artery Clamping for Laparoscopic Cesarean Scar Niche Repair
A Phase 2 study testing Vasopressin Group and Bulldog Clamping Group in people with Cesarean Section Complications, run by Zagazig University at 1 site in Saudi Arabia.
Trial summary
This study evaluates two methods for controlling intraoperative bleeding during laparoscopic surgery to repair a cesarean scar niche (CSN). It compares the effectiveness of intramyometrial vasopressin injection against bilateral temporary clamping of the uterine arteries using laparoscopic bulldog clips. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Vasopressin Group and Bulldog Clamping Group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 20 Mar 2024to 15 Jan 2026
- Phase
- Phase 2
- 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 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Diagnosis of symptomatic CSN.
- Scheduled for laparoscopic excision and repair.
Who cannot join
- Contraindications to vasopressin (e.g., severe hypertension or cardiovascular disease).
- Presence of other major uterine pathologies (e.g., large myomas or malignancy).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Noninferiority of Intramyometrial Vasopressin Injection Compared to Bilateral Temporary Clamping of Uterine Arteries During Laparoscopic Excision and Repair of Cesarean Scar Niche
This study evaluates two methods for controlling intraoperative bleeding during laparoscopic surgery to repair a cesarean scar niche (CSN). It compares the effectiveness of intramyometrial vasopressin injection against bilateral temporary clamping of the uterine arteries using laparoscopic bulldog clips. The goal is to determine if vasopressin injection is non-inferior to arterial clamping in reducing blood loss and maintaining surgical field visibility.
- Conditions
- Cesarean Section Complications
- Being tested
- Vasopressin Group, Bulldog Clamping Group, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vasopressin GroupDrug
Patients receive a local injection of 12 mL of diluted vasopressin into the myometrium directly surrounding the cesarean scar niche. This is performed during the laparoscopic procedure, just before the excision of the fibrous scar tissue, to constrict local blood vessels and minimize intraoperative bleeding.
Bulldog Clamping GroupProcedure or surgery
This intervention involves the temporary mechanical clamping of both uterine arteries using laparoscopic bulldog vascular clips. The clips are applied to block blood flow to the uterus before the niche is excised and are removed once the myometrial reconstruction is complete.
Standard of CareProcedure or surgery
Approach: A 3-port laparoscopic approach using Storz endoscopic instruments.
Excision: Complete removal of the fibrous scar tissue surrounding the niche defect.
Reconstruction: Suturing and repair of the myometrium to resolve the defect.
| Study group | Role | What they receive |
|---|---|---|
| Vasopressin Group (Group V) | Active comparator | Patients receiving intramyometrial injection of diluted vasopressin (12 mL) surrounding the niche before excision. Receives: Drug: Vasopressin Group; Procedure: Standard of Care |
| Uterine Artery Clamping Group (Group B) | Active comparator | Patients undergoing bilateral temporary uterine artery occlusion (BUAO) using laparoscopic bulldog vascular clips before niche excision. Receives: Procedure: Bulldog Clamping Group; Procedure: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Hemoglobin Deficit Mean Hemoglobin Deficit
The difference between preoperative and postoperative hemoglobin concentrations, used as a primary indicator of intraoperative blood loss.
Measured: 24 hours post-surgery.
Secondary outcomes (2)
Surgical Field Visibility (SFV) Score
Assessment of the clarity of the surgical field using Boezaart's scale (0-5), where lower scores indicate better visibility.
Measured: Intraoperative
Total Operative Time
Duration of the surgical procedure from the initial incision to the completion of myometrial reconstruction.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start20 Mar 2024
- Primary completion17 Oct 2025
- Study completion15 Jan 2026
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.
- More trials run by Zagazig 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bassem Mohamed Talaat Abdelaziz Ali, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446933
- Sponsor's protocol ID
- N#3/2024
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 3 Mar 2026
- 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 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninferiority of Intramyometrial Vasopressin Injection Compared to Bilateral Temporary Clamping of Uterine Arteries During Laparoscopic Excision and Repair of Cesarean Scar Niche
- ClinicalTrials.gov ID
- NCT07446933
- Acronym / sponsor ID
- N#3/2024
- Conditions
- Cesarean Section Complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 17 Oct 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 3 Mar 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 evaluates two methods for controlling intraoperative bleeding during laparoscopic surgery to repair a cesarean scar niche (CSN). It compares the effectiveness of intramyometrial vasopressin injection against bilateral temporary clamping of the uterine arteries using laparoscopic bulldog clips. The goal is to determine if vasopressin injection is non-inferior to arterial clamping in reducing blood loss and maintaining surgical field visibility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vasopressin Group (Group V) | Active comparator | Drug: Vasopressin Group, Procedure: Standard of CarePatients receiving intramyometrial injection of diluted vasopressin (12 mL) surrounding the niche before excision. |
| Uterine Artery Clamping Group (Group B) | Active comparator | Procedure: Bulldog Clamping Group, Procedure: Standard of CarePatients undergoing bilateral temporary uterine artery occlusion (BUAO) using laparoscopic bulldog vascular clips before niche excision. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of symptomatic CSN.
- Scheduled for laparoscopic excision and repair.
Key exclusion criteria (2 listed)
- Contraindications to vasopressin (e.g., severe hypertension or cardiovascular disease).
- Presence of other major uterine pathologies (e.g., large myomas or malignancy).
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 |
|---|---|---|
| Vasopressin GroupPatients receive a local injection of 12 mL of diluted vasopressin into the myometrium directly surrounding the cesarean scar niche. This is performed during the laparoscopic procedure, just before the excision of the fibrous scar tissue, to constrict local blood vessels and minimize intraoperative bleeding. | Drug | Vasopressin Group (Group V) |
| Bulldog Clamping GroupThis intervention involves the temporary mechanical clamping of both uterine arteries using laparoscopic bulldog vascular clips. The clips are applied to block blood flow to the uterus before the niche is excised and are removed once the myometrial reconstruction is complete. | Procedure or surgery | Uterine Artery Clamping Group (Group B) |
| Standard of CareApproach: A 3-port laparoscopic approach using Storz endoscopic instruments. Excision: Complete removal of the fibrous scar tissue surrounding the niche defect. Reconstruction: Suturing and repair of the myometrium to resolve the defect. | Procedure or surgery | Uterine Artery Clamping Group (Group B), Vasopressin Group (Group V) |
Primary outcome
Mean Hemoglobin Deficit Mean Hemoglobin Deficit
Time frame: 24 hours post-surgery.
The difference between preoperative and postoperative hemoglobin concentrations, used as a primary indicator of intraoperative blood loss.
2 secondary outcomes
Surgical Field Visibility (SFV) Score
Time frame: Intraoperative
Total Operative Time
Time frame: Intraoperative
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 Mar 2026.
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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 Phase 2 study testing Vasopressin Group and Bulldog Clamping Group in people with Cesarean Section Complications, run by Zagazig University at 1 site in Saudi Arabia.
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 2 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 Mar 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 Saudi Arabia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Mean Hemoglobin Deficit Mean Hemoglobin Deficit (time frame: 24 hours post-surgery.). 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 Mar 2026.