Menstrual IrregularityNCT06768879
Sonographic Evaluation Of Uterine Fibroids At Different Locations In Patient With Irregular Menstrul Cycle
An observational study of Menstrual Irregularity, run by Superior University at 1 site in Pakistan.
Trial summary
Uterine fibroids are a major cause of illness in women of a reproductive age. There are many factors involved in the growth and reduction of these common tumors. The most likely cause of fibroids is their effect on a woman's menstrual cycle. Read more about this study
- Who is it for?
- Ages 15 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Irregularity
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 97 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Feb 2024to 1 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 15 to 35 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Aim is to check Irregular Menstrul Cycle with Sonographic Evaluation Of Uterine Fibroids
Who may be able to join
- Patient with Pelvic pain
- Patient with Abdominal pain
- Patient with heavy bleeding
- Patient with Dysmenorrhea
- Polymenorrhea
Who cannot join
- Patient with H/O Cystectomy
- Patient with H/O cyst
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
THQ hospital Pattoki/ Siddique medical center Pattoki
Pattoki, Punjab Province
About this study
Uterine fibroids are a major cause of illness in women of a reproductive age. There are many factors involved in the growth and reduction of these common tumors. The most likely cause of fibroids is their effect on a woman's menstrual cycle. For accurate diagnosis numerous diagnostic markers on ultrasound are present which increases the efficacy of ultrasound to diagnose uterine fibroids.
Read the detailed description
To evaluate the different location of uterine fibroids in patient with disturbed menstrual cycle on Ultrasound.
The descriptive and cross-sectional study was conducted. A total of 97 patient data were collected. All the patients with uterine fibroids due to heavy bleeding, abdominal pain, pelvic pain, disturbance in menstrual cycle undergoing ultrasound were included.
- Conditions
- Menstrual Irregularity
- Being tested
- Ultrasound
- Medical subject headings
- Menstruation Disturbances
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundRadiation
To evaluate the different location of uterine fibroids in patient with disturbed menstrual cycle on ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
two-dimensional ultrasound scan (GE Loginq P7 convex probe.3.5-5MHz)
On ultrasound using (GE Loginq P7 convex probe.3.5-5MHz), a uterine fibroid is classically characterized as a solid, round, well-defined, hypoechoic, heterogeneous lesion within the myometrium, often showing acoustic shadowing at the edge of the lesion
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start25 Feb 2024
- Primary completion8 Aug 2024
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menstrual IrregularityStudies of the same condition, open and under way.
- More trials run by Superior 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 97 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768879
- Sponsor's protocol ID
- MSAHS/Batch-Spring23/033
- Status last verified
- Jan 2025
- First submitted
- 18 Dec 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Evaluation Of Uterine Fibroids At Different Locations In Patient With Irregular Menstrul Cycle
- ClinicalTrials.gov ID
- NCT06768879
- Acronym / sponsor ID
- MSAHS/Batch-Spring23/033
- Conditions
- Menstrual Irregularity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 97 participants (estimated)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 10 Jan 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.
Uterine fibroids are a major cause of illness in women of a reproductive age. There are many factors involved in the growth and reduction of these common tumors. The most likely cause of fibroids is their effect on a woman's menstrual cycle. For accurate diagnosis numerous diagnostic markers on ultrasound are present which increases the efficacy of ultrasound to diagnose uterine fibroids.
Detailed description
To evaluate the different location of uterine fibroids in patient with disturbed menstrual cycle on Ultrasound.
The descriptive and cross-sectional study was conducted. A total of 97 patient data were collected. All the patients with uterine fibroids due to heavy bleeding, abdominal pain, pelvic pain, disturbance in menstrual cycle undergoing ultrasound were included.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Aim is to check Irregular Menstrul Cycle with Sonographic Evaluation Of Uterine Fibroids
Key inclusion criteria (5 listed)
- Patient with Pelvic pain
- Patient with Abdominal pain
- Patient with heavy bleeding
- Patient with Dysmenorrhea
- Polymenorrhea
Key exclusion criteria (2 listed)
- Patient with H/O Cystectomy
- Patient with H/O cyst
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 |
|---|---|---|
| UltrasoundTo evaluate the different location of uterine fibroids in patient with disturbed menstrual cycle on ultrasound | Radiation | – |
Primary outcome
two-dimensional ultrasound scan (GE Loginq P7 convex probe.3.5-5MHz)
Time frame: 12 Months
On ultrasound using (GE Loginq P7 convex probe.3.5-5MHz), a uterine fibroid is classically characterized as a solid, round, well-defined, hypoechoic, heterogeneous lesion within the myometrium, often showing acoustic shadowing at the edge of the lesion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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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?
An observational study of Menstrual Irregularity, run by Superior University at 1 site in Pakistan.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 10 Jan 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
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?
two-dimensional ultrasound scan (GE Loginq P7 convex probe.3.5-5MHz) (time frame: 12 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 Jan 2025.