Drug AddictionSanté-FemNCT07033728
The Health of Women Monitored in the Addiction Department of the Strasbourg University Hospitals
An observational study of Drug Addiction, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The health of women suffering from addiction is little known and little explored in the literature. Indeed, they represent only 20% of addicted patients in general and are encountered primarily during pregnancy or complex situations involving young children. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Drug Addiction
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 24 Mar 2025to 24 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female, adult (≥ 18 years old) undergoing follow-up at the CSAPA Addictions Department of the HUS
Who may be able to join
- Female, adult (≥ 18 years old)
- Undergoing follow-up at the CSAPA Addictions Department of the HUS
- Having met the team's midwife at least once
- Absence of written objection in the patient's medical record regarding the reuse of her data for scientific research purposes.
Who cannot join
- Absence of written objection in the patient's medical record regarding the reuse of her data for scientific research purposes
- Female minor
- Female who has not initiated follow-up with the CSAPA team
- Women who have never had a consultation with the team's midwife
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'addictologie - CHU de Strasbourg - France
Strasbourg, 67091
Cécile NORTH, Midwife, 33 3 88 11 51 62, cecile.wohlfahrt@chru-strasbourg.fr
Laurence LALANNE, MD, PhD, 33 3 88 11 64 25, Laurence.lalanne@chru-strasbourg.fr
About this study
The health of women suffering from addiction is little known and little explored in the literature. Indeed, they represent only 20% of addicted patients in general and are encountered primarily during pregnancy or complex situations involving young children.
In the Addiction Department of Strasbourg University Hospitals, the investigators have established a midwifery consultation exclusively for women of all ages.
During the treatment of the women, the investigators were able to identify the specific issues faced by women suffering from addiction and the specific care requirements for this population.
- Conditions
- Drug Addiction
- Keywords
- Drug Addiction, Addiction
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of gynecological follow-up regardless of age compared to the general population
This is a retrospective study to carry out an inventory of the health status of women treated at the CSAPA (Center for Addiction Care, Support, and Prevention) of the HUS (University Hospitals of Strasbourg)
Measured: Up to 18 months
Secondary outcomes (2)
Rate of Consumption of toxic drugs compared to the general population
This is a retrospective study to carry out an inventory of the health status of women treated at the CSAPA (Center for Addiction Care, Support, and Prevention) of the HUS (University Hospitals of Strasbourg)
Measured: Up to 18 months
Rate of sexual violence compared to the general population
This is a retrospective study to carry out an inventory of the health status of women treated at the CSAPA (Center for Addiction Care, Support, and Prevention) of the HUS (University Hospitals of Strasbourg)
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start24 Mar 2025
- Primary completion24 Sep 2026 (estimated)
- Study completion24 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AddictionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033728
- Sponsor's protocol ID
- 9616
- Acronym
- Santé-Fem
- Status last verified
- May 2025
- First submitted
- 16 May 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Health of Women Monitored in the Addiction Department of the Strasbourg University Hospitals
- ClinicalTrials.gov ID
- NCT07033728
- Acronym / sponsor ID
- Santé-Fem / 9616
- Conditions
- Drug Addiction
- Keywords
- Drug Addiction, Addiction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 24 Sep 2026 (estimated)
- Study completion
- 24 Sep 2026 (estimated)
- First posted
- 24 Jun 2025 (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.
The health of women suffering from addiction is little known and little explored in the literature. Indeed, they represent only 20% of addicted patients in general and are encountered primarily during pregnancy or complex situations involving young children.
In the Addiction Department of Strasbourg University Hospitals, the investigators have established a midwifery consultation exclusively for women of all ages.
During the treatment of the women, the investigators were able to identify the specific issues faced by women suffering from addiction and the specific care requirements for this population.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female, adult (≥ 18 years old) undergoing follow-up at the CSAPA Addictions Department of the HUS
Key inclusion criteria (4 listed)
- Female, adult (≥ 18 years old)
- Undergoing follow-up at the CSAPA Addictions Department of the HUS
- Having met the team's midwife at least once
- Absence of written objection in the patient's medical record regarding the reuse of her data for scientific research purposes.
Key exclusion criteria (4 listed)
- Absence of written objection in the patient's medical record regarding the reuse of her data for scientific research purposes
- Female minor
- Female who has not initiated follow-up with the CSAPA team
- Women who have never had a consultation with the team's midwife
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
Rate of gynecological follow-up regardless of age compared to the general population
Time frame: Up to 18 months
This is a retrospective study to carry out an inventory of the health status of women treated at the CSAPA (Center for Addiction Care, Support, and Prevention) of the HUS (University Hospitals of Strasbourg)
2 secondary outcomes
Rate of Consumption of toxic drugs compared to the general population
Time frame: Up to 18 months
Rate of sexual violence compared to the general population
Time frame: Up to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
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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.
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 Drug Addiction, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cécile NORTH, Midwife (33 3 88 11 51 62, cecile.wohlfahrt@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of gynecological follow-up regardless of age compared to the general population (time frame: Up to 18 months). 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 24 Jun 2025.