- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05688228
Voluntary Interruption of Pregnancy on Women's Sexuality (VTOPSimpact)
Description of the Evolution of Women's Sexuality After a Voluntary Interruption of Pregnancy
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.
Study Overview
Detailed Description
The medical consequences of abortion are low. However, there is an undeniable emotional and psychological impact on these women (40-45% of anxiety-type symptoms, approximately 20% of depressive symptoms after the discovery of the pregnancy and 30% of emotional disorders, particularly anxiety, in the month following the abortion).
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 voluntary termination of pregnancy (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 a termination.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France
- CHU Bordeaux
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patient (≥ 18 years)
- Patient performing a medical or surgical abortion
- Patient with health insurance
- No opposition to participation in the study
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Abortion
Adult women performing a medical or surgical abortion
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Female Sexual Function Index (FSFI) and self-administrative questionnaires on sexuality just after abortion and repeated at 1, 3 and 6 months
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of patients with sexual dysfunction
Time Frame: Month 6
|
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
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Month 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Marital status
Time Frame: Baseline
|
single, couple, married
|
Baseline
|
|
Number of sexual partners in the last 12 months
Time Frame: Baseline
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Number of sexual partners via self-questionnaire : 1 ; from 2 to 5 ; from 6 to 10 ; from 11 to 15 ; from 16 to 20 ; up to 20
|
Baseline
|
|
Number of sexual partners in the whole life
Time Frame: Baseline
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Number of sexual partners via self-questionnaire : 1 ; from 2 to 5 ; from 6 to 10 ; from 11 to 15 ; from 16 to 20 ; up to 20
|
Baseline
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Number of sexual partners in the last 4 weeks
Time Frame: Baseline
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Number of sexual partners via self-questionnaire : 0, 1, from 2 to 5, up to 5
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Baseline
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Frequency of sexual activity in the last month before pregnancy discovery
Time Frame: Baseline, Month 1, Month 3, Month 6
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< 1 /month ; from 1 from 3 /month ; 1 /week ; twice /week ; 3 or more times /week
|
Baseline, Month 1, Month 3, Month 6
|
|
Existence of physical violence in the whole life
Time Frame: Baseline
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binary variable (yes/no)
|
Baseline
|
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Existence of psychological violence in the whole life
Time Frame: Baseline
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binary variable (yes/no)
|
Baseline
|
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Existence of sexual violence in the whole life
Time Frame: Baseline
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binary variable (yes/no)
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Baseline
|
|
Existence of psychological symptoms before pregnancy's discovery
Time Frame: Baseline
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asthenia, sadness, anxiety, guilt, none
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Baseline
|
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Existence of psychological symptoms in the last month
Time Frame: Month 1, Month 3, Month 6
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asthenia, sadness, anxiety, guilt, none
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Month 1, Month 3, Month 6
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Existence of sexual difficulties since pregnancy's discovery
Time Frame: Baseline
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Decreased desire, arousal, lubrication, quantity or quality of orgasms, sexual satisfaction or relationship with the partner, appearance or increase of pain during sexual intercourse, no change in these different areas of sexuality
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Baseline
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Sexual activity the last month
Time Frame: Month 1, Month 3, Month 6
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Decreased sexual activity (fear of another pregnancy, waiting to start contraception, conflict with partner after abortion, other reason), Not concerned about decreased sexual activity
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Month 1, Month 3, Month 6
|
|
Contraception in the last month
Time Frame: Month 1, Month 3, Month 6
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none, removal/cycles, condoms, pill, intrauterine devic, implant, ring/patch, other
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Month 1, Month 3, Month 6
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHUBX 2022/71
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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