Female Genital MutilationNCT04802330
PREVALENCE OF FEMALE GENITAL MUTILATION IN BENI-SUEF LOCALITIES
An observational study of Female Genital Mutilation, run by Beni-Suef University at 1 site in Egypt.
Trial summary
Female genital mutilation /cutting (FGMC) includes all procedures that involve partial or total removal of the external female genitalia, or another injury to the female genital organs for non-medical reasons". Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Female Genital Mutilation
- What is being tested?
- Questionnaire
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2021to May 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 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population consisted of all males and females who will be attended to the previously mentioned study setting at the time of data collection will be included in the study.
Who may be able to join
- Living in Beni Suef Governorate.
Who cannot join
- Women and men who complaining of any psychological problems
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Nesreen Abdel Fattah Abdallah Shehata
Cairo, 11211
Nesreen A. A. Shehata, MD, 00201024150605, nesoomar@yahoo.com
Momen Z. Elnadeim, MD, 00201000063692, mzakariaelnadeim@med.bsu.edu.eg
About this study
Official title: PREVALENCE OF FEMALE GENITAL MUTILATION IN BENI SUEF LOCALITIES
Female genital mutilation /cutting (FGMC) includes all procedures that involve partial or total removal of the external female genitalia, or another injury to the female genital organs for non-medical reasons". It constitutes an extreme form of discrimination against women due to the health consequences, pain, and risks involved. Regardless of its prevalence, the physical and psychological complications of FGM in Egypt were shown to be enormous. These complications are usually categorized into primary or acute complications and secondary or long-term complications. The primary complications include pain, bleeding, and psychiatric trauma while the secondary complications include several emotional, menstrual, and sexual disorders
Read the detailed description
Despite being internationally recognized as a human rights violation of girls and women, FGM has been performed on at least 200 million girls and women in 31 countries. According to the 2015 Egypt Health Issues Survey (EHIS), 87% of all women aged 15-49 years in Egypt had undergone FGM. Social norms, religion, ensuring premarital virginity and marital fidelity, increasing marriageability, and cultural ideals of femininity and modesty were among the most commonly cited reasons for performing FGM. A survey conducted among Egyptians aged 10-29 years in 2014 indicated that the reasons given for practicing FGM were customs and traditions (56.7%) and religion (35%).
FGM has many types ranging from excision of the prepuce with/out clitoris (Type I or Clitoridectomy) and excision of the clitoris and labia minora (Type II or Excision) to profound excision of the external genitalia with stitching and tightening the vaginal opening (Type III or Infibulation). Type IV describes pricking, piercing, scraping, and cauterization of the external genitalia without flesh removal. In societies with Muslim majorities, type I: is known as "Sunna Circumcision"; a religious term linking the practice to the commands of the Prophet of Islam or "Khifad" the Arabic synonym of "reduction"; a term claiming that the Prophet of Islam endorsed partial rather than complete excision of the external genitalia. In Egypt, types I and II are also called "Ta-hara"; the Arabic synonym of "purification" which points to the hygienic drive of the practice.
- Conditions
- Female Genital Mutilation
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Assessment of causes of FGM Beni Suef localities. 3. Explore the relationship between some of the social and demographic variables such as age, education, place of residence, marital status, religion and economic level and practice of FGM.
| Study group | Role | What they receive |
|---|---|---|
| Female genital mutilation | Assessment of FGM prevalence in Beni Suef localities and its impact on studied women. Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the impact of FGM
The investigators will evaluate the consequences of female genital mutilation on participants of the study.
Measured: During 13 months
To estimate intention to practice FGM
The participants will be given questions concerning intention to practice FGM in future. This section included questions regarding females' plans of mutilating their daughters in future, whether they were facing social pressure from family members or neighbors, whether they knew someone who intended to mutilate their daughters.
Measured: During 13 months
Secondary outcomes (1)
To collect information about history of circumcision for the woman and her daughter.
A questionnaire rituals of FGM and the decision-maker.
Measured: During 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study startApr 2021 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Female Genital MutilationStudies of the same condition, open and under way.
- More trials run by Beni-Suef 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802330
- Sponsor's protocol ID
- Beni-Suef 21
- Status last verified
- Mar 2021
- First submitted
- 15 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdou, Marwa SM, Iman MH Wahdan, and Nessrin A. El-Nimr.
Shell-Duncan B. The medicalization of female "circumcision": harm reduction or promotion of a dangerous practice? Soc Sci Med. 2001 Apr;52(7):1013-28. doi: 10.1016/s0277-9536(00)00208-2.
PubMed 11266046Tag-Eldin MA, Gadallah MA, Al-Tayeb MN, Abdel-Aty M, Mansour E, Sallem M. Prevalence of female genital cutting among Egyptian girls. Bull World Health Organ. 2008 Apr;86(4):269-74. doi: 10.2471/blt.07.042093.
PubMed 18438515
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREVALENCE OF FEMALE GENITAL MUTILATION IN BENI SUEF LOCALITIES
- ClinicalTrials.gov ID
- NCT04802330
- Acronym / sponsor ID
- Beni-Suef 21
- Conditions
- Female Genital Mutilation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 17 Mar 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.
Female genital mutilation /cutting (FGMC) includes all procedures that involve partial or total removal of the external female genitalia, or another injury to the female genital organs for non-medical reasons". It constitutes an extreme form of discrimination against women due to the health consequences, pain, and risks involved. Regardless of its prevalence, the physical and psychological complications of FGM in Egypt were shown to be enormous. These complications are usually categorized into primary or acute complications and secondary or long-term complications. The primary complications include pain, bleeding, and psychiatric trauma while the secondary complications include several emotional, menstrual, and sexual disorders
Detailed description
Despite being internationally recognized as a human rights violation of girls and women, FGM has been performed on at least 200 million girls and women in 31 countries. According to the 2015 Egypt Health Issues Survey (EHIS), 87% of all women aged 15-49 years in Egypt had undergone FGM. Social norms, religion, ensuring premarital virginity and marital fidelity, increasing marriageability, and cultural ideals of femininity and modesty were among the most commonly cited reasons for performing FGM. A survey conducted among Egyptians aged 10-29 years in 2014 indicated that the reasons given for practicing FGM were customs and traditions (56.7%) and religion (35%).
FGM has many types ranging from excision of the prepuce with/out clitoris (Type I or Clitoridectomy) and excision of the clitoris and labia minora (Type II or Excision) to profound excision of the external genitalia with stitching and tightening the vaginal opening (Type III or Infibulation). Type IV describes pricking, piercing, scraping, and cauterization of the external genitalia without flesh removal. In societies with Muslim majorities, type I: is known as "Sunna Circumcision"; a religious term linking the practice to the commands of the Prophet of Islam or "Khifad" the Arabic synonym of "reduction"; a term claiming that the Prophet of Islam endorsed partial rather than complete excision of the external genitalia. In Egypt, types I and II are also called "Ta-hara"; the Arabic synonym of "purification" which points to the hygienic drive of the practice.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female genital mutilation | – | Other: QuestionnaireAssessment of FGM prevalence in Beni Suef localities and its impact on studied women. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consisted of all males and females who will be attended to the previously mentioned study setting at the time of data collection will be included in the study.
Key inclusion criteria (1 listed)
- Living in Beni Suef Governorate.
Key exclusion criteria (1 listed)
- Women and men who complaining of any psychological problems
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 |
|---|---|---|
| QuestionnaireAssessment of causes of FGM Beni Suef localities. 3. Explore the relationship between some of the social and demographic variables such as age, education, place of residence, marital status, religion and economic level and practice of FGM. | Other | Female genital mutilation |
Primary outcome
Assessment of the impact of FGM
Time frame: During 13 months
The investigators will evaluate the consequences of female genital mutilation on participants of the study.
To estimate intention to practice FGM
Time frame: During 13 months
The participants will be given questions concerning intention to practice FGM in future. This section included questions regarding females' plans of mutilating their daughters in future, whether they were facing social pressure from family members or neighbors, whether they knew someone who intended to mutilate their daughters.
1 secondary outcome
To collect information about history of circumcision for the woman and her daughter.
Time frame: During 13 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- BackgroundAbdou, Marwa SM, Iman MH Wahdan, and Nessrin A. El-Nimr.
- Background: PubMed 11266046Shell-Duncan B. The medicalization of female "circumcision": harm reduction or promotion of a dangerous practice? Soc Sci Med. 2001 Apr;52(7):1013-28. doi: 10.1016/s0277-9536(00)00208-2.
- Background: PubMed 18438515Tag-Eldin MA, Gadallah MA, Al-Tayeb MN, Abdel-Aty M, Mansour E, Sallem M. Prevalence of female genital cutting among Egyptian girls. Bull World Health Organ. 2008 Apr;86(4):269-74. doi: 10.2471/blt.07.042093.
- 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.
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, run by Beni-Suef 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 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 17 Mar 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 Nesreen A.A. Shehata, MD (00201024150605, nesoomar@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the impact of FGM (time frame: During 13 months). The study lists 2 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 NCT04802330, which also lists 3 linked publications.
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 17 Mar 2021.