Cesarean Section Niche and Abnormal Uterine BleedingNCT05067296
Prevalance of Cesarean Section Niche in Patients With Abnormal Uterine Bleeding
An observational study of Cesarean Section Niche and Abnormal Uterine Bleeding, run by Mahmoud Ramadan Hafez at 1 site in Egypt.
Trial summary
Prevalance of Cesarean section niche in patients with abnormal uterine bleeding Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Cesarean Section Niche and Abnormal Uterine Bleeding
- What is being tested?
- By TVS
- How many people
- 1 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 Aug 2022
- Phase
- Observational
- 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 20 to 40 years
- Women only
- Adult
Study population: Prevalance of Cesarean section niche in patients with abnormal uterine bleeding
Who may be able to join
- Age between 20-40 years old. Non pregnant women. Previous cesarean section (one or more). Presence of abnormal uterine bleeding
Who cannot join
- Virgins Pregnant women. Patients with vaginal delivery. Patients with uterine bleeding with known cause.
Trial locations and contacts
1 site in 1 country.
Sabry M Mohamed, Professor Dr contact
About this study
Prevalance of Cesarean section niche in patients with abnormal uterine bleeding
- Being tested
- By TVS
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
By TVSOther
Uses of TVS to diagnosis of Cesarean section niche in patients with abnormal uterine bleeding
| Study group | Role | What they receive |
|---|---|---|
| Cesarean section niche and patients with abnormal uterine bleeding | Observation by Tvs Receives: Other: By TVS | |
| Abnormal uterine bleeding in patients without Cesarean section niche | Observation by Tvs Receives: Other: By TVS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean section niche in patients with abnormal uterine bleeding
To study relationship between the niche and the abnormal uterine bleeding
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start1 Oct 2021 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section Niche and Abnormal Uterine BleedingStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahmoud Ramadan Hafez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mahmoud Ramadan Hafez, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067296
- Sponsor's protocol ID
- Soh-Med-21-09-06
- Status last verified
- Sep 2021
- First submitted
- 23 Sep 2021
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalance of Cesarean Section Niche in Patients With Abnormal Uterine Bleeding
- ClinicalTrials.gov ID
- NCT05067296
- Acronym / sponsor ID
- Soh-Med-21-09-06
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Mahmoud Ramadan HafezUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 5 Oct 2021 (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.
Prevalance of Cesarean section niche in patients with abnormal uterine bleeding
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cesarean section niche and patients with abnormal uterine bleeding | – | Other: By TVSObservation by Tvs |
| Abnormal uterine bleeding in patients without Cesarean section niche | – | Other: By TVSObservation by Tvs |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Prevalance of Cesarean section niche in patients with abnormal uterine bleeding
Key inclusion criteria (1 listed)
- Age between 20-40 years old. Non pregnant women. Previous cesarean section (one or more). Presence of abnormal uterine bleeding
Key exclusion criteria (1 listed)
- Virgins Pregnant women. Patients with vaginal delivery. Patients with uterine bleeding with known cause.
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 |
|---|---|---|
| By TVSUses of TVS to diagnosis of Cesarean section niche in patients with abnormal uterine bleeding | Other | Abnormal uterine bleeding in patients without Cesarean section niche, Cesarean section niche and patients with abnormal uterine bleeding |
Primary outcome
Cesarean section niche in patients with abnormal uterine bleeding
Time frame: 6 months
To study relationship between the niche and the abnormal uterine bleeding
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
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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.
Sabry M Mohamed, Professor Dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Niche and Abnormal Uterine Bleeding, run by Mahmoud Ramadan Hafez 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud R Hafez, Resident (01095070933, Albaraky2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cesarean section niche in patients with abnormal uterine bleeding (time frame: 6 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 5 Oct 2021.