Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03486522
Recruitment Status : Unknown
Verified March 2018 by Célia Lloret-Linares, MD PhD, Hopital Lariboisière.
Recruitment status was:  Recruiting
First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Célia Lloret-Linares, MD PhD, Hopital Lariboisière

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
STD

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
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 : March 16, 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. STDs prevalence [ Time Frame: 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All women, of age or not, with a pregnancy less than 14 weeks of amenorrhae, who came to the family planning centre of Obstetrics Dpt, Lariboisière Hospital, for a termination of pregnancy, able to give a written consent for the Survey.
Criteria

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03486522


Contacts
Layout table for location contacts
Contact: Olivier Paccoud, M.D. + 33 149956339 opaccoud@hotmail.com
Contact: Pierre O Sellier, M.D., Ph.D. + 33 149956339 pierre.sellier@aphp.fr

Locations
Layout table for location information
France
Family Planning Centre, Obstetrics Dpt, Lariboisière Hosp, Recruiting
Paris, Ile-de-France, France, 75475
Contact: Olivier Paccoud, M.D.    +33 149956339    opaccoud@hotmail.com   
Contact: Pierre O Sellier, M.D., Ph.D.    +33 149956339    pierre.sellier@aphp.fr   
Sponsors and Collaborators
Hopital Lariboisière
Investigators
Layout table for investigator information
Study Director: Pierre O Sellier, M.D., Ph.D. Assistance Publique - Hôpitaux de Paris
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Célia Lloret-Linares, MD PhD, PI, Hopital Lariboisière
ClinicalTrials.gov Identifier: NCT03486522    
Other Study ID Numbers: 2018-A00144-51
First Posted: April 3, 2018    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: March 2018

Layout table for additional information
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, Hopital Lariboisière:
termination of pregnancy