STDDEP-IST-IVGNCT03486522
STD Screening in Women Admitted in Family Planning for a Termination of Pregnancy
An observational study of STD, run by Hopital Lariboisière at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- STD
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 16 Mar 2018to Jan 2019
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Family Planning Centre, Obstetrics Dpt, Lariboisière Hosp,
Paris, Île-de-France Region, 75475
Olivier Paccoud, M.D., +33 149956339, opaccoud@hotmail.com
Pierre O Sellier, M.D., Ph.D., +33 149956339, pierre.sellier@aphp.fr
About this study
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.
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.
Read the 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.
- Conditions
- STD
- Keywords
- termination of pregnancy
What is being measured
The primary outcome is the main question the study is designed to answer.
STDs prevalence
Prevalence of STDs (C trachomatis, N gonorrhoae, T pallidum, HIV, HBV, HCV, HPV) in women in a family planning centre
Measured: Up to 30 days after termination of pregnancy (period of follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start16 Mar 2018
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Hopital Lariboisière
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Célia Lloret-Linares, MD PhD, Hopital Lariboisière
- Investigators
- Pierre O Sellier, M.D., Ph.D., Study director, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486522
- Sponsor's protocol ID
- 2018-A00144-51
- Acronym
- DEP-IST-IVG
- Status last verified
- Mar 2018
- First submitted
- 18 Mar 2018
- Last updated
- 3 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03486522
- Acronym / sponsor ID
- DEP-IST-IVG / 2018-A00144-51
- Conditions
- STD
- Keywords
- termination of pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hopital LariboisièreUniversity, hospital or other
- Study start
- 16 Mar 2018 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 3 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre O Sellier, M.D., Ph.D. study director
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STD, run by Hopital Lariboisière at 1 site in France.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Paccoud, M.D. (+ 33 149956339, opaccoud@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STDs prevalence (time frame: Up to 30 days after termination of pregnancy (period of follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.