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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04802330
Other study ID # Beni-Suef 21
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2021
Est. completion date May 2021

Study information

Verified date March 2021
Source Beni-Suef University
Contact Nesreen A.A. Shehata, MD
Phone 00201024150605
Email nesoomar@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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". 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date May 2021
Est. primary completion date May 2021
Accepts healthy volunteers No
Gender All
Age group 21 Years to 45 Years
Eligibility Inclusion Criteria: - Living in Beni Suef Governorate. Exclusion Criteria: - Women and men who complaining of any psychological problems

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire
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.

Locations

Country Name City State
Egypt Nesreen Abdel Fattah Abdallah Shehata Cairo

Sponsors (1)

Lead Sponsor Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. Review. — View Citation

Tag-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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of the impact of FGM The investigators will evaluate the consequences of female genital mutilation on participants of the study. During 13 months
Primary 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. During 13 months
Secondary To collect information about history of circumcision for the woman and her daughter. A questionnaire rituals of FGM and the decision-maker. During 13 months
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06027281 - Consequences of Female Genital Mutilation on Married Women.