NCT03486522

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 18, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 3, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 3, 2018

Status Verified

March 1, 2018

Enrollment Period

9 months

First QC Date

March 18, 2018

Last Update Submit

March 31, 2018

Conditions

STD

Keywords

termination of pregnancy

Outcome Measures

Primary Outcomes (1)

  • STDs prevalence

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

    Up to 30 days after termination of pregnancy (period of follow-up)

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • Not able to to give a written consent for the Survey
  • Women with legal guardian
  • Women who refused to take part to the survey

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Planning Centre, Obstetrics Dpt, Lariboisière Hosp,

Paris, Île-de-France Region, 75475, France

RECRUITING

Study Officials

  • Pierre O Sellier, M.D., Ph.D.

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Central Study Contacts

Olivier Paccoud, M.D.

CONTACT

+ 33 149956339opaccoud@hotmail.com

Pierre O Sellier, M.D., Ph.D.

CONTACT

+ 33 149956339pierre.sellier@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

March 18, 2018

First Posted

April 3, 2018

Study Start

March 16, 2018

Primary Completion

December 1, 2018

Study Completion

January 1, 2019

Last Updated

April 3, 2018

Record last verified: 2018-03

Locations

FR(1)