PregnancyADDGESTNCT03567070
Pregnancy and Use of Psychoactive Substances: The Influence of Representations of Care on Care.
A study testing qualitative study based on an individual clinical interview in people with Pregnancy, run by University Hospital, Caen at 1 site in France.
Trial summary
It is observed that pregnant women using psychoactive substance (s) have a more random and more accidental pregnancy follow-up than women with no addictive problems. The consumption approach can be either omitted during the pregnancy monitoring, or entrusted to the course or more often in late pregnancy or occurs more… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- qualitative study based on an individual clinical interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 17 Mar 2017to 12 Jun 2018
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major patients
- Pregnant or having given birth since <28 days
- Having used (whether declared or discovered incidentally) - regardless of the amount of psychoactive substance (s) during pregnancy: alcohol, and / or heroin or OST, and / or cannabis, and / or psychostimulants (cocaine, ecstasy, amphetamines)
- Followed or not in addictology during pregnancy
Who cannot join
- Minor patients
- Patients under legal protection (guardianship, guardianship)
- Linguistic obstacle
- Psychiatric pathology decompensated at the time of the meeting
- Women who only used tobacco regularly during pregnancy
- Women who have only regularly used psychoactive drugs and / or licit opiates (excluding prescription replacement products) during pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
It is observed that pregnant women using psychoactive substance (s) have a more random and more accidental pregnancy follow-up than women with no addictive problems.
The consumption approach can be either omitted during the pregnancy monitoring, or entrusted to the course or more often in late pregnancy or occurs more brutally during delivery at the time of complications (neonatal or obstetric). In this context, health professionals are looking for levers that allow women to take appropriate care quickly.
Read more
This difficulty of access to care questions us and all the more because the time of the pregnancy is a moment of important psychic reorganization conducive to modify its habits, to change its glance on its consumptions and thus to start a care concerning addiction.
Invesigators hypothesize that this population has less access to medical care during pregnancy for fear of stigmatization by the health care provider.
Invesigators propose a multicenter qualitative study based on individual clinical interviews to collect the testimony of women who used psychoactive substance (s) during their pregnancy.
The purpose of this work is to identify ways to improve the multidisciplinary medical management of these women by focusing on the representations they can make care of.
- Conditions
- Pregnancy
- Being tested
- qualitative study based on an individual clinical interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
qualitative study based on an individual clinical interviewOther
qualitative study based on an individual clinical interview
| Study group | Role | What they receive |
|---|---|---|
| qualitative study based on an individual clinical interview | Other | Not described Receives: Other: qualitative study based on an individual clinical interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
individual clinical interview
qualitative study based on an individual clinical interview
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start17 Mar 2017
- Primary completion24 Aug 2017
- Study completion12 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03567070
- Sponsor's protocol ID
- 17-050
- Acronym
- ADDGEST
- Status last verified
- Jun 2018
- First submitted
- 12 Jun 2018
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy and Use of Psychoactive Substances: The Influence of Representations of Care on Care.
- ClinicalTrials.gov ID
- NCT03567070
- Acronym / sponsor ID
- ADDGEST / 17-050
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 17 Mar 2017 (actual)
- Primary completion
- 24 Aug 2017 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 25 Jun 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.
It is observed that pregnant women using psychoactive substance (s) have a more random and more accidental pregnancy follow-up than women with no addictive problems.
The consumption approach can be either omitted during the pregnancy monitoring, or entrusted to the course or more often in late pregnancy or occurs more brutally during delivery at the time of complications (neonatal or obstetric). In this context, health professionals are looking for levers that allow women to take appropriate care quickly.
This difficulty of access to care questions us and all the more because the time of the pregnancy is a moment of important psychic reorganization conducive to modify its habits, to change its glance on its consumptions and thus to start a care concerning addiction.
Invesigators hypothesize that this population has less access to medical care during pregnancy for fear of stigmatization by the health care provider.
Invesigators propose a multicenter qualitative study based on individual clinical interviews to collect the testimony of women who used psychoactive substance (s) during their pregnancy.
The purpose of this work is to identify ways to improve the multidisciplinary medical management of these women by focusing on the representations they can make care of.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| qualitative study based on an individual clinical interview | Other | Other: qualitative study based on an individual clinical interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Major patients
- Pregnant or having given birth since <28 days
- Having used (whether declared or discovered incidentally) - regardless of the amount of psychoactive substance (s) during pregnancy: alcohol, and / or heroin or OST, and / or cannabis, and / or psychostimulants (cocaine, ecstasy, amphetamines)
- Followed or not in addictology during pregnancy
Key exclusion criteria (6 listed)
- Minor patients
- Patients under legal protection (guardianship, guardianship)
- Linguistic obstacle
- Psychiatric pathology decompensated at the time of the meeting
- Women who only used tobacco regularly during pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| qualitative study based on an individual clinical interviewqualitative study based on an individual clinical interview | Other | qualitative study based on an individual clinical interview |
Primary outcome
individual clinical interview
Time frame: baseline
qualitative study based on an individual clinical interview
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing qualitative study based on an individual clinical interview in people with Pregnancy, run by University Hospital, Caen 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 6 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: finished, as of the sponsor's last update on 25 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
individual clinical interview (time frame: baseline). 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 25 Jun 2018.