Pregnancy and Use of Psychoactive Substances: The Influence of Representations of Care on Care. (ADDGEST)

June 21, 2018 updated by: University Hospital, Caen

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France
        • Caen University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: qualitative study based on an individual clinical interview
Other: qualitative study based on an individual clinical interview
qualitative study based on an individual clinical interview

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
individual clinical interview
Time Frame: baseline
qualitative study based on an individual clinical interview
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2017

Primary Completion (Actual)

August 24, 2017

Study Completion (Actual)

June 12, 2018

Study Registration Dates

First Submitted

June 12, 2018

First Submitted That Met QC Criteria

June 21, 2018

First Posted (Actual)

June 25, 2018

Study Record Updates

Last Update Posted (Actual)

June 25, 2018

Last Update Submitted That Met QC Criteria

June 21, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 17-050

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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