Pregnancy and Use of Psychoactive Substances: The Influen... | NCT03567070

Studies
Pregnancy and Use of Psychoactive Substances: The Influence of Representations of Care on Care.

NCT03567070

Sponsor

University Hospital, Caen

Status

Completed

Last Update Posted

Jun 25, 2018Actual

Enrollment

9Actual

Phase

Not Applicable

Conditions

Pregnancy

Interventions

qualitative study based on an individual clinical interview

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2017Actual

Primary Completion Date

Aug 24, 2017Actual

Completion Date

Jun 12, 2018Actual

First Submitted Date

Jun 12, 2018

First Submission Date that Met QC Criteria

Jun 21, 2018

First Posted Date

Jun 25, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2018

Last Update Posted Date

Jun 25, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
qualitative study based on an individual clinical interview	Other		Other: qualitative study based on an individual clinical interview

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnancy

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Caen University Hospital		Caen			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided