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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05688228
Other study ID # CHUBX 2022/71
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 27, 2023
Est. completion date February 10, 2024

Study information

Verified date May 2024
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 209
Est. completion date February 10, 2024
Est. primary completion date February 10, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
questionnaire
Female Sexual Function Index (FSFI) and self-administrative questionnaires on sexuality just after abortion and repeated at 1, 3 and 6 months

Locations

Country Name City State
France CHU Bordeaux Bordeaux

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Marital status single, couple, married Baseline
Secondary Number of sexual partners in the last 12 months 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
Secondary Number of sexual partners in the whole life 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
Secondary Number of sexual partners in the last 4 weeks Number of sexual partners via self-questionnaire : 0, 1, from 2 to 5, up to 5 Baseline
Secondary Frequency of sexual activity in the last month before pregnancy discovery < 1 /month ; from 1 from 3 /month ; 1 /week ; twice /week ; 3 or more times /week Baseline, Month 1, Month 3, Month 6
Secondary Existence of physical violence in the whole life binary variable (yes/no) Baseline
Secondary Existence of psychological violence in the whole life binary variable (yes/no) Baseline
Secondary Existence of sexual violence in the whole life binary variable (yes/no) Baseline
Secondary Existence of psychological symptoms before pregnancy's discovery asthenia, sadness, anxiety, guilt, none Baseline
Secondary Existence of psychological symptoms in the last month asthenia, sadness, anxiety, guilt, none Month 1, Month 3, Month 6
Secondary Existence of sexual difficulties since pregnancy's discovery 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 Baseline
Secondary Sexual activity the last month Decreased sexual activity (fear of another pregnancy, waiting to start contraception, conflict with partner after abortion, other reason), Not concerned about decreased sexual activity Month 1, Month 3, Month 6
Secondary Contraception in the last month none, removal/cycles, condoms, pill, intrauterine devic, implant, ring/patch, other Month 1, Month 3, Month 6
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