Voluntary Interruption of Pregnancy on Women's Sexuality (VTOPSimpact)

May 7, 2024 updated by: University Hospital, Bordeaux

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

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

209

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bordeaux, France
        • CHU Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women performing a medical or surgical abortion

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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 last 4 weeks
Time Frame: Baseline
Number of sexual partners via self-questionnaire : 0, 1, from 2 to 5, up to 5
Baseline
Frequency of sexual activity in the last month before pregnancy discovery
Time Frame: Baseline, Month 1, Month 3, Month 6
< 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
binary variable (yes/no)
Baseline
Existence of psychological violence in the whole life
Time Frame: Baseline
binary variable (yes/no)
Baseline
Existence of sexual violence in the whole life
Time Frame: Baseline
binary variable (yes/no)
Baseline
Existence of psychological symptoms before pregnancy's discovery
Time Frame: Baseline
asthenia, sadness, anxiety, guilt, none
Baseline
Existence of psychological symptoms in the last month
Time Frame: Month 1, Month 3, Month 6
asthenia, sadness, anxiety, guilt, none
Month 1, Month 3, Month 6
Existence of sexual difficulties since pregnancy's discovery
Time Frame: Baseline
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
Sexual activity the last month
Time Frame: Month 1, Month 3, Month 6
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
Contraception in the last month
Time Frame: Month 1, Month 3, Month 6
none, removal/cycles, condoms, pill, intrauterine devic, implant, ring/patch, other
Month 1, Month 3, Month 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2023

Primary Completion (Actual)

February 10, 2024

Study Completion (Actual)

February 10, 2024

Study Registration Dates

First Submitted

December 28, 2022

First Submitted That Met QC Criteria

January 13, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 7, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CHUBX 2022/71

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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