ProlapseNCT03820089
Evaluation of TP US in Women With Prolapse
An observational study of Prolapse, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Many women suffers from uterine and vaginal prolapse Usually they suffer from these symotoms in menopause Read more about this study
- Who is it for?
- Ages 25 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prolapse
- What is being tested?
- Ultrasonography TP
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Jan 2019to 25 Jan 2020
- How long will I take part?
- 8 Weeks
- 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 25 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women who complains from genital prolapse with previous normal deliveries
Who may be able to join
- Women with history of normal delivery Age between 25 to 75 years
Who cannot join
- women with cesarean deliveries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of TP US Assesment of Women With Prolapse
Many women suffers from uterine and vaginal prolapse Usually they suffer from these symotoms in menopause
Read the detailed description
The most common cause of pelvic organ prolapse is multiple pregnancy and multiparity
- Conditions
- Prolapse
- Being tested
- Ultrasonography TP
- Medical subject headings
- Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography TPDiagnostic test
TP us will be made to the included women
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of women who will be properly diagnosed with prolapse by TP us
The accuracy of TP US in diagnosing the prolapse
Measured: within 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2019
- Study start29 Jan 2019
- Primary completion20 Jan 2020
- Study completion25 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProlapseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor
- Investigators
- Mahmoud Alalfy, PhD, Principal investigator, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03820089
- Sponsor's protocol ID
- prolapse
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2019
- Last updated
- 10 Feb 2022
- 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 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of TP US Assesment of Women With Prolapse
- ClinicalTrials.gov ID
- NCT03820089
- Acronym / sponsor ID
- prolapse
- Conditions
- Prolapse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 25 Jan 2020 (actual)
- First posted
- 29 Jan 2019 (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.
Many women suffers from uterine and vaginal prolapse Usually they suffer from these symotoms in menopause
Detailed description
The most common cause of pelvic organ prolapse is multiple pregnancy and multiparity
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
Who may qualify
- Ages
- 25 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women who complains from genital prolapse with previous normal deliveries
Key inclusion criteria (1 listed)
- Women with history of normal delivery Age between 25 to 75 years
Key exclusion criteria (1 listed)
- women with cesarean deliveries
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 |
|---|---|---|
| Ultrasonography TPTP us will be made to the included women | Diagnostic test | – |
Primary outcome
The number of women who will be properly diagnosed with prolapse by TP us
Time frame: within 2 months
The accuracy of TP US in diagnosing the prolapse
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 10 Feb 2022.
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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.
Mahmoud Alalfy, PhD principal investigator
Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt
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 Prolapse, run by Aljazeera Hospital 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: finished, as of the sponsor's last update on 10 Feb 2022. 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?
The number of women who will be properly diagnosed with prolapse by TP us (time frame: within 2 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 10 Feb 2022.