Female Genital Mutilation Type I StatusFMG-HCPROFNCT04936386
Knowledge and Perspective of Healthcare Professionals About Female Genital Mutation
An observational study of Female Genital Mutilation Type I Status and Female Genital Mutilation Type II Status, run by Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia at 1 site in Italy.
Trial summary
Each year over three million girls are at risk of being subjected to female genital mutilation (FGM) in several African countries. This regional survey aims to evaluate knowledge and perspective of healthcare professionals related to FGM. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Female Genital Mutilation Type I Status, Female Genital Mutilation Type II Status, Female Genital Mutilation Type III Status
- What is being tested?
- Survey
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 450 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2021to 31 Jul 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthcare professionals working in Genoa
Who may be able to join
- medical specialists
- general medical practicians
- medical residents
- midwives
- professional nurses
- medical students
- residence in Liguria (Italy)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Knowledge and Perspective of Healthcare Professionals Related to Female Genital Mutation: a Regional Survey
Each year over three million girls are at risk of being subjected to female genital mutilation (FGM) in several African countries. This regional survey aims to evaluate knowledge and perspective of healthcare professionals related to FGM.
Read the detailed description
The survey iscomposed of 4 different sections: the first section included questions about demographic data of participants; the second part evaluated responders' knowledge about FGM; the third section focused on participants' working experience with patients affected by FGM and personal attitude related to this topic.
- Conditions
- Female Genital Mutilation Type I Status, Female Genital Mutilation Type II Status, Female Genital Mutilation Type III Status
- Being tested
- Survey
- Keywords
- female genital mutilation, healthcare professionals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyBehavioural
The survey is composed of 4 different sections: the first section included questions about demographic data of participants; the second part evaluated responders' knowledge about FGM; the third section focused on participants' working experience with patients affected by FGM and personal attitude related to this topic.
| Study group | Role | What they receive |
|---|---|---|
| Healthcare professionals | Healthcare professionals (medical specialists and general practitioners, medical residents, midwives, professional nurses, medical students). Receives: Behavioral: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean score related to knowledge about FGM
10-point score (0:minimal knowledge; 10: extensive knowledge) related to the knowledge of responders about FGM
Measured: Baseline
Proportion of responders with active role in contrasting the procedures
Evalution of the personale attitude of responders to the topic (active role in contrasting the procedures)
Measured: Baseline
Proportion of responders feeling confortable in treating patients affected
Evalution of the personale attitude of responders to the topic (responders feeling confortable in treating patients affected)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Apr 2021
- Primary completion30 Jun 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Female Genital Mutilation Type I StatusStudies 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
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simone Ferrero, Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936386
- Sponsor's protocol ID
- FMG-HEALTHCAREPROF-SURVEY
- Acronym
- FMG-HCPROF
- Status last verified
- Feb 2022
- First submitted
- 19 Jun 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Abdulcadir J, Catania L, Hindin MJ, Say L, Petignat P, Abdulcadir O. Female Genital Mutilation: A Visual Reference and Learning Tool for Health Care Professionals. Obstet Gynecol. 2016 Nov;128(5):958-963. doi: 10.1097/AOG.0000000000001686.
PubMed 27741194
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge and Perspective of Healthcare Professionals Related to Female Genital Mutation: a Regional Survey
- ClinicalTrials.gov ID
- NCT04936386
- Acronym / sponsor ID
- FMG-HCPROF / FMG-HEALTHCAREPROF-SURVEY
- Conditions
- Female Genital Mutilation Type I Status, Female Genital Mutilation Type II Status, Female Genital Mutilation Type III Status
- Keywords
- female genital mutilation, healthcare professionals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Piazza della Vittoria 14 Studio Medico - Ginecologia e OstetriciaUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 23 Jun 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.
Each year over three million girls are at risk of being subjected to female genital mutilation (FGM) in several African countries. This regional survey aims to evaluate knowledge and perspective of healthcare professionals related to FGM.
Detailed description
The survey iscomposed of 4 different sections: the first section included questions about demographic data of participants; the second part evaluated responders' knowledge about FGM; the third section focused on participants' working experience with patients affected by FGM and personal attitude related to this topic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthcare professionals | – | Behavioral: SurveyHealthcare professionals (medical specialists and general practitioners, medical residents, midwives, professional nurses, medical students). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthcare professionals working in Genoa
Key inclusion criteria (7 listed)
- medical specialists
- general medical practicians
- medical residents
- midwives
- professional nurses
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| SurveyThe survey is composed of 4 different sections: the first section included questions about demographic data of participants; the second part evaluated responders' knowledge about FGM; the third section focused on participants' working experience with patients affected by FGM and personal attitude related to this topic. | Behavioural | Healthcare professionals |
Primary outcome
Mean score related to knowledge about FGM
Time frame: Baseline
10-point score (0:minimal knowledge; 10: extensive knowledge) related to the knowledge of responders about FGM
Proportion of responders with active role in contrasting the procedures
Time frame: Baseline
Evalution of the personale attitude of responders to the topic (active role in contrasting the procedures)
Proportion of responders feeling confortable in treating patients affected
Time frame: Baseline
Evalution of the personale attitude of responders to the topic (responders feeling confortable in treating patients affected)
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 7 Feb 2022.
- Background: PubMed 27741194Abdulcadir J, Catania L, Hindin MJ, Say L, Petignat P, Abdulcadir O. Female Genital Mutilation: A Visual Reference and Learning Tool for Health Care Professionals. Obstet Gynecol. 2016 Nov;128(5):958-963. doi: 10.1097/AOG.0000000000001686.
- Individual participant dataSharing planned: Undecided
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 Female Genital Mutilation Type I Status and Female Genital Mutilation Type II Status, run by Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia at 1 site in Italy.
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 7 inclusion and 0 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 7 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 Italy. 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?
Mean score related to knowledge about FGM (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04936386, which also lists 1 linked publication.
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 7 Feb 2022.