Cesarean Section ComplicationsNCT07095647
Surgical Management of Cesarean Scar Ectopic Pregnancy: Hysteroscopy & Laparoscopy Outcomes
A study testing Hysteroscopy in people with Cesarean Section Complications, run by Benha University at 1 site in Egypt.
Trial summary
The study investigates the feasibility, safety, and outcomes of a simultaneous surgical approach for cesarean scar ectopic pregnancy (CSEP). CSEP is a prevalent and serious form of ectopic pregnancy requiring swift intervention. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Hysteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 20 May 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 25 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with positive clinical and lab pregnancy diagnosis;
- Patients with history of at least one previous Cesarean section;
- Patients with Transvaginal ultrasound documenting Cesarean scar ectopic Pregnancy;
Who cannot join
- Patients with were extensive adhesions between the mass and the urinary bladder on MRI;
- Patients with myomas, polyps, endometrial hyperplasia, and cancers of the cervix or endometrium;
- Patients with a body mass index (BMI) of >35kg/m2;
- Patients with previous abdominal surgeries with possible difficulties during laparoscopy;
- Patients with menstrual irregularities, or coagulation disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Outcomes of Simultaneous Hysteroscopy/Laparoscopy for Cesarean-Section Niche Ectopic Pregnancy Management and Uterine Niche Repair
The study investigates the feasibility, safety, and outcomes of a simultaneous surgical approach for cesarean scar ectopic pregnancy (CSEP). CSEP is a prevalent and serious form of ectopic pregnancy requiring swift intervention. The research explores using hysteroscopy and laparoscopy concurrently to manage the CSEP and repair the uterine scar defect. The procedure involved hysteroscopic-guided evacuation and a double-layer laparoscopic repair, followed by a second hysteroscopy to confirm the repair's effectiveness.
- Conditions
- Cesarean Section Complications
- Being tested
- Hysteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysteroscopyProcedure or surgery
Hysteroscopic-guided suction evacuation and double-layer laparoscopic repair of the niche were performed concomitantly and followed by second-look hysteroscopy to ensure the competence of the repair.
| Study group | Role | What they receive |
|---|---|---|
| Cesarean Scar Ectopic Pregnancy Patients (CSEP) | Other | Patients presenting pregnant with a history of at least one previous Cesarean Section, and Transvaginal ultrasound documentation of Cesarean Scar Ectopic Pregnancy. Receives: Procedure: Hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Hysteroscopy in Restoring the normal endometrial metrics, and removing any uterine defects.
The proportion of patients who restored their normal endometrial metrics and removed any uterine scars during the study, reflecting the effectiveness of the applied Hystreoscopy regimens.
Measured: 6~7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Oct 2024
- Primary completion15 Apr 2025
- Study completion20 May 2025
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 Benha 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Naguib, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095647
- Sponsor's protocol ID
- RC 9.6.2025
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcomes of Simultaneous Hysteroscopy/Laparoscopy for Cesarean-Section Niche Ectopic Pregnancy Management and Uterine Niche Repair
- ClinicalTrials.gov ID
- NCT07095647
- Acronym / sponsor ID
- RC 9.6.2025
- Conditions
- Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 20 May 2025 (actual)
- First posted
- 31 Jul 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.
The study investigates the feasibility, safety, and outcomes of a simultaneous surgical approach for cesarean scar ectopic pregnancy (CSEP). CSEP is a prevalent and serious form of ectopic pregnancy requiring swift intervention. The research explores using hysteroscopy and laparoscopy concurrently to manage the CSEP and repair the uterine scar defect. The procedure involved hysteroscopic-guided evacuation and a double-layer laparoscopic repair, followed by a second hysteroscopy to confirm the repair's effectiveness.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cesarean Scar Ectopic Pregnancy Patients (CSEP) | Other | Procedure: HysteroscopyPatients presenting pregnant with a history of at least one previous Cesarean Section, and Transvaginal ultrasound documentation of Cesarean Scar Ectopic Pregnancy. |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with positive clinical and lab pregnancy diagnosis;
- Patients with history of at least one previous Cesarean section;
- Patients with Transvaginal ultrasound documenting Cesarean scar ectopic Pregnancy;
Key exclusion criteria (5 listed)
- Patients with were extensive adhesions between the mass and the urinary bladder on MRI;
- Patients with myomas, polyps, endometrial hyperplasia, and cancers of the cervix or endometrium;
- Patients with a body mass index (BMI) of >35kg/m2;
- Patients with previous abdominal surgeries with possible difficulties during laparoscopy;
- Patients with menstrual irregularities, or coagulation 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 |
|---|---|---|
| HysteroscopyHysteroscopic-guided suction evacuation and double-layer laparoscopic repair of the niche were performed concomitantly and followed by second-look hysteroscopy to ensure the competence of the repair. | Procedure or surgery | Cesarean Scar Ectopic Pregnancy Patients (CSEP) |
Primary outcome
Success Rate of Hysteroscopy in Restoring the normal endometrial metrics, and removing any uterine defects.
Time frame: 6~7 months
The proportion of patients who restored their normal endometrial metrics and removed any uterine scars during the study, reflecting the effectiveness of the applied Hystreoscopy regimens.
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 31 Jul 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 Hysteroscopy 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 5 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 31 Jul 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?
Success Rate of Hysteroscopy in Restoring the normal endometrial metrics, and removing any uterine defects. (time frame: 6~7 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 31 Jul 2025.