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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03567070
Other study ID # 17-050
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 17, 2017
Est. completion date June 12, 2018

Study information

Verified date June 2018
Source University Hospital, Caen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date June 12, 2018
Est. primary completion date August 24, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
qualitative study based on an individual clinical interview
qualitative study based on an individual clinical interview

Locations

Country Name City State
France Caen University Hospital Caen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary individual clinical interview qualitative study based on an individual clinical interview baseline
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