Voluntary Interruption of Pregnancy on Women's Sexuality

Abortion Clinical Trial

— VTOPSimpact  

Official title:

Description of the Evolution of Women's Sexuality After a Voluntary Interruption of Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05688228
• Other study ID #: CHUBX 2022/71
• Status: Recruiting
• Start date: February 27, 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: February 2023
• Source: University Hospital, Bordeaux
• Contact: Dounia Baïta, MD
• Phone: +335 56 79 58 88
• Email: dounia.baita[@]chu-bordeaux.fr
• Is FDA regulated: No
• 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: Recruiting
• Enrollment: 186
• Est. completion date: October 1, 2023
• Est. primary completion date: October 1, 2023
• 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.

Related Conditions & MeSH terms

• Abortion

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