Voluntary Interruption of Pregnancy on Women's Sexuality
VTOPSimpact
Description of the Evolution of Women's Sexuality After a Voluntary Interruption of Pregnancy
1 other identifier
observational
209
1 country
1
Brief Summary
The impact on sexuality has been less studied and there is no French study on this subject and the rare studies are contradictory. The aim of this study is to evaluate the impact of abortion (medical or surgical) on female sexuality, to look for a difference in the impact on sexuality according to the method used for the termination (medical or surgical) just after the procedure and at 1, 3 and 6 months and to look for risk factors and protective factors for the existence or occurrence of sexual dysfunction before and after abortion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2022
CompletedFirst Posted
Study publicly available on registry
January 18, 2023
CompletedStudy Start
First participant enrolled
February 27, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 10, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2024
CompletedMay 8, 2024
May 1, 2024
12 months
December 28, 2022
May 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients with sexual dysfunction
Sexual dysfunction is assessed using the Female Sexual Function Index (FSFI) questionnaire, which takes into account several aspects of female sexuality: desire, arousal, lubrication, orgasm, satisfaction and pain. The threshold for differentiating between patients with and without sexual dysfunction is 26.55
Month 6
Secondary Outcomes (13)
Marital status
Baseline
Number of sexual partners in the last 12 months
Baseline
Number of sexual partners in the whole life
Baseline
Number of sexual partners in the last 4 weeks
Baseline
Frequency of sexual activity in the last month before pregnancy discovery
Baseline, Month 1, Month 3, Month 6
- +8 more secondary outcomes
Study Arms (1)
Abortion
Adult women performing a medical or surgical abortion
Interventions
Female Sexual Function Index (FSFI) and self-administrative questionnaires on sexuality just after abortion and repeated at 1, 3 and 6 months
Eligibility Criteria
Women performing a medical or surgical abortion
You may qualify if:
- Adult patient (≥ 18 years)
- Patient performing a medical or surgical abortion
- Patient with health insurance
- No opposition to participation in the study
You may not qualify if:
- Patient who does not speak French and/or is illiterate
- Patient under legal protection
- Patient unable to complete the study procedures (no internet connection, no smart phone or tablet)
- Patient with diagnosed psychiatric comorbidities.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Bordeaux
Bordeaux, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 28, 2022
First Posted
January 18, 2023
Study Start
February 27, 2023
Primary Completion
February 10, 2024
Study Completion
February 10, 2024
Last Updated
May 8, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share