Supporting Women Towards Risk Reduction and Management of... | NCT06194266

Studies
Supporting Women Towards Risk Reduction and Management of Gynecological and Obstetric Issues

NCT06194266

Sponsor

University Hospital, Strasbourg, France

Status

Completed

Last Update Posted

Mar 13, 2024Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Gynecologic Nursing

Interventions

Not provided

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

Dec 2023

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

Jul 17, 2023Actual

Primary Completion Date

Sep 17, 2023Actual

Completion Date

Sep 17, 2023Actual

First Submitted Date

Dec 18, 2023

First Submission Date that Met QC Criteria

Jan 5, 2024

First Posted Date

Jan 8, 2024Actual

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

Mar 12, 2024

Last Update Posted Date

Mar 13, 2024Actual

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

The health of women who use drugs is a real public health issue where the midwife has an important role to play in the multidisciplinary support of the Center for Care, Support and Prevention in Addictology (CSAPA).

The main objective is to identify the needs and expectations of the women received in terms of reducing risks and damage at the gynecological and obstetric level.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retrospective description of the needs and expectations of women in terms of gyneco-obstetric risk reduction		Through study completion, an average of 1 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Eligibility Criteria:

Adult women (≥ 18 years old)
Followed at the Center for Care, Support and Prevention in Addictology (CSAPA) of the University Hospitals of Strasbourg
Speaking and understanding French
Agreeing to participate anonymously in this study

Exclusion Criteria:

Refusal to participate in the study

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

- Adult women (≥ 18 years old) followed at the Center for Care, Support and Prevention in Addictology (CSAPA) of the University Hospitals of Strasbourg

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Addictologie - CHU de Strasbourg - France		Strasbourg		67091	France