NCT04802330

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 15, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

1 month

First QC Date

March 15, 2021

Last Update Submit

March 15, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Assessment of the impact of FGM

    The investigators will evaluate the consequences of female genital mutilation on participants of the study.

    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.

    During 13 months

Secondary Outcomes (1)

  • To collect information about history of circumcision for the woman and her daughter.

    During 13 months

Study Arms (1)

Female genital mutilation

Assessment of FGM prevalence in Beni Suef localities and its impact on studied women.

Other: Questionnaire

Interventions

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.

Female genital mutilation

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Living in Beni Suef Governorate.

You may not qualify if:

  • Women and men who complaining of any psychological problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nesreen Abdel Fattah Abdallah Shehata

Cairo, 11211, Egypt

Location

Related Publications (3)

  • Abdou, Marwa SM, Iman MH Wahdan, and Nessrin A. El-Nimr.

    BACKGROUND
  • 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.

    PMID: 11266046BACKGROUND
  • 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. doi: 10.2471/blt.07.042093.

    PMID: 18438515BACKGROUND

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Nesreen A.A. Shehata, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Obstetrics and Gynecology Department

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 17, 2021

Study Start

April 1, 2021

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

March 17, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations