FGM Sister Study: Exploring the views of female genital mutilation/cutting survivors, male partners and healthcare professionals on the timing of re-opening surgery

Not Applicable

Completed

• Conditions: Female genital mutilation/cutting; Urological and Genital Diseases; Female genital mutilation/cutting (FGM/C)

• Registration Number: ISRCTN14710507
• Lead Sponsor: niversity of Birmingham

Brief Summary

2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31628134 protocol (added 21/10/2019) 2023 Results article in https://doi.org/10.3310/jhwe4771 (added 23/03/2023) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36572653/ primary outcome measure (added 23/03/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-17
• Study Completion: 2020-09-30
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 141

Inclusion Criteria

Work packages 1a and 2a:
1. Female
2. Aged 18 years or older
3. UK resident
4. Fluent in English, Somali, Arabic and/or French
5. Experienced female genital mutilation/cutting (FGM/C)
6. Willing and able to provide written informed consent.

Work package 1b:
1. Male
2. Aged 18 years or older
3. UK resident
4. Fluent in English, Somali, Arabic and/or French
5. Partner/wife or family member who has experienced FGM/C
6. Willing and able to provide written informed consent.

Work package 1c:
1. Aged 18 years or older
2. Fluent in English
3. Healthcare professional, including but not limited to:
3.1. General practitioners
3.2. Practice nurses
3.3. Midwives
3.4. Obstetrics and gynaecology clinicians
3.5. Genitourinary clinicians
3.6. Sexual health specialists
4. Currently or recently involved (within the last 5 years) in the delivery of care to FGM/C survivors and their families in the UK
5. Willing and able to provide written informed consent

Work package 2b:
1. Aged 18 years or older
2. Fluent in English
3. Key FGM/C stakeholder, including but not limited to:
3.1. Healthcare professionals (see list for work package 1c)
3.2. Policy makers
3.3. FGM/C specialist researchers/academics
3.4. Health economists
3.5. Commissioners
3.6. Representatives from third sector organisations (e.g. charities and advocacy groups)
4. Currently or recently involved (within the last 5 years) in the delivery of care to FGM/C survivors and their families in the UK
5. Willing and able to provide written informed consent

Exclusion Criteria

Work packages 1a and 2a:
1. Psychological distress related to FGM/C, which prevents them from consenting and/or participating

Work package 1b:
1. Partner/wife does not consent to their participation (if identified via a WP1a participant)
2. Psychological distress related to FGM/C, which prevents them from consenting and/or participating

Work packages 1c and 2b have no exclusion criteria.

Study & Design

• Study Type: Other
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
An understanding of how FGM/C-survivors’, their male partners’ and HCPs’ preferences for the timing of deinfibulation and their views on how NHS services can best be delivered to meet the needs of FGM/C-survivors and their families. Data will be qualitative (with the exception of a non-validated demographic questionnaire that will allow us to describe the sample of participants) in nature including field notes, audio files and transcripts. Participants in work package 1 will take part in a one off interview or discussion group lasting between 60 and 90 minutes. Data will be collected over a 12-month period. Participants in work package 2 will take part in a one off discussion group lasting between 3 and 4 hours. Data will be collected over a six month period.