NCT03567070

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 25, 2018

Completed
Last Updated

June 25, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

June 12, 2018

Last Update Submit

June 21, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • individual clinical interview

    qualitative study based on an individual clinical interview

    baseline

Study Arms (1)

qualitative study based on an individual clinical interview

OTHER
Other: qualitative study based on an individual clinical interview

Interventions

qualitative study based on an individual clinical interview

qualitative study based on an individual clinical interview

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnancy
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2018

First Posted

June 25, 2018

Study Start

March 17, 2017

Primary Completion

August 24, 2017

Study Completion

June 12, 2018

Last Updated

June 25, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations