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DEP-IST-IVG: STD Screening in Women Admitted in Family Planning for a Termination of Pregnancy

Sponsor
Hopital Lariboisière (Other)
Overall Status
Unknown status
CT.gov ID
NCT03486522
Collaborator
(none)
200
Enrollment
1
Location
9.6
Anticipated Duration (Months)
20.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Epidemiology of Sexually Transmitted Diseases (STDs) in women admitted in a Family Planning for a termination of pregnancy is poorly defined currently in France. Only one bi-centre study (Bourgeois-Nicolaos, 2015), performed in two Family Planning suburban centres located within University Hospital (Assistance Publique-Hôpitaux de Paris), found high prevalence: C. trachomatis 15.1%, N. gonorrhoeae 3.1%. Moreover, heterogeneity can occur between centres. In students in Sweden, 26% had one or several previous STDs, mainly C. trachomatis and Human Papilloma Virus (HPV). Having previously a termination of pregnancy was a risk factor of STDs. Systematic screening for STDs in Women Admitted in Family Planning for a Termination of Pregnancy appears thus a logical strategy.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Epidemiology of Sexually Transmitted Diseases (STDs) in women admitted in a Family Planning for a termination of pregnancy is poorly defined currently in France. Only one bi-centre study (Bourgeois-Nicolaos, 2015), performed in two Family Planning suburban centres located within University Hospital (Assistance Publique-Hôpitaux de Paris), found high prevalence: C. trachomatis 15.1%, N. gonorrhoeae 3.1%. Moreover, heterogeneity can occur between centres. In students in Sweden, 26% had one or several previous STDs, mainly C. trachomatis and Human Papilloma Virus (HPV). Risk factors in univariate analysis were tobacco smoking, a previous termination of pregnancy, lack of vaccination against HPV, having sexual intercourse precociously, number of sexual partners, anal sex, having sexual intercourse without consent, having unprotected sex during last intercourse. Risk factors in multivariate analysis were a previous termination of pregnancy, lack of vaccination against HPV, number of sexual partners, having sexual intercourse without consent, having unprotected sex during last intercourse. Systematic screening for STDs in Women Admitted in Family Planning for a Termination of Pregnancy appears thus a logical strategy.

    In a previous study performed in Emergency Dpt in an University Hospital (Assistance Publique-Hôpitaux de Paris), screening patients born in sub-Saharan Africa, French Indies and French Guyana, prevalence 1.8% (6 times national prevalence), 7.8% and 3.6% for HIV, HBV and HCV was found respectively. Ile-de-France is the area of France with the highest HBV prevalence (133/100 000); moreover, most women with HBsAg positive are of child-bearing age. From the 24,000 women with HBsAg positive 18-39 years old, only 5700 (24%) are aware of their status. Similarly, Ile-de-France is the area of France with the highest HCV prevalence (109/100 000), with women 20-29 and 30-39 years old accounting for 15% each. HCV nationale prévalence is 3.1% in people born in sub-Saharan Africa, 1.4% in people born in Asia, 10.2% in people born in Middle-East.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Screening for Sexually Transmitted Diseases (STDs) in Women Admitted in Family Planning, Lariboisière Hospital, for a Termination of Pregnancy: a Prospective Systematic Survey.
    Actual Study Start Date :
    Mar 16, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2018
    Anticipated Study Completion Date :
    Jan 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. STDs prevalence [Up to 30 days after termination of pregnancy (period of follow-up)]

      Prevalence of STDs (C trachomatis, N gonorrhoae, T pallidum, HIV, HBV, HCV, HPV) in women in a family planning centre

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: Women of age or not coming for a termination of pregnancy able to give a written consent for the survey

    Exclusion Criteria:Women coming for another reason than a termination of pregnancy

    • Not able to to give a written consent for the Survey

    • Women with legal guardian

    • Women who refused to take part to the survey

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Family Planning Centre, Obstetrics Dpt, Lariboisière Hosp, Paris Ile-de-France France 75475

    Sponsors and Collaborators

    • Hopital Lariboisière

    Investigators

    • Study Director: Pierre O Sellier, M.D., Ph.D., Assistance Publique - Hôpitaux de Paris

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Célia Lloret-Linares, MD PhD, PI, Hopital Lariboisière
    ClinicalTrials.gov Identifier:
    NCT03486522
    Other Study ID Numbers:
    • 2018-A00144-51
    First Posted:
    Apr 3, 2018
    Last Update Posted:
    Apr 3, 2018
    Last Verified:
    Mar 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Célia Lloret-Linares, MD PhD, PI, Hopital Lariboisière
    termination of pregnancy

    Study Results

    No Results Posted as of Apr 3, 2018