- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06921954
Study Effects of the PRECAPP System on Precarious and Vulnerable Pregnant Women
The themes of city-hospital coordination, patient pathways and the decompartmentalization of the city-hospital-medical-social and social sectors are becoming a major preoccupation for the healthcare sector, and a key factor in its dynamic transformation. A number of initiatives taken in this direction, either by the regulatory authorities (development of tools to promote coordination between healthcare professionals), by hospital establishments or by city professionals (notably CPTS), attest to a growing interest in the subject.
The École des Mines de Paris, whose highly collaborative research methods (research-intervention) are anchored in concrete support for transformation projects, and the University of Lille (LUMEN) are thus increasingly called upon to support players in these areas.
In this context, collaborative work with a Quebec research team (Ecole Nationale d'Administration Publique and Université de Sherbrooke) was launched in 2023 to compare forms of healthcare pathway management between two different healthcare systems, and their effects on vulnerable people (elderly, disabled, migrants, homeless, etc.). In France, the quantitative component is based on the use of PMSI databases, and aims to analyze the characteristics of "abnormally long" patient stays, in order to identify variables (relating either to patients or to care) likely to explain longer lengths of stay. The qualitative component is based on interviews with professionals and the reconstruction of patient pathways marked by breaks in care. The aim is to understand the very notion of breakdowns, the mechanisms by which they occur and the strategies put in place to avoid or deal with them.
Collaboration with the PRECAPP research team
As part of the qualitative component of the research program, the French team met several times between February and summer 2024 with members of the PRECAPP program. The PRECAPP system's function (to support vulnerable pregnant women in the perinatal period) and its mission (to identify the risks of disruption to care as early as possible in pregnancy, and to coordinate care during pregnancy and in the postnatal period) are at the heart of the Franco-Quebec research.
An initial working meeting between the PRECAPP team and the researchers provided an opportunity to describe the system and to demonstrate that its operation and the specific support it provides make it possible to anticipate certain difficulties in the care of women (before, during and after birth) and to help avoid disruptions in care.
The PRECAPP system is therefore fully in line with a comprehensive approach to the perinatal care of precarious and vulnerable women. This care concerns intra-hospital care, but it also contributes to the decompartmentalization of city-hospital care.
It is with the aim of highlighting the contributions of the PRECAPP system to the quality of care provided, the limits to its action, and to assess the way in which it helps to avoid breakdowns, that a collaboration between researchers and practitioners has been set up and will enable this study to be carried out.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
- Age ≥ 18 years
- Follow-up in 2023 at Gonesse Hospital
- Patient having started her PRECAPP follow-up in 2023, between the 2nd and 5th month of pregnancy and having been accompanied throughout her PRECAPP journey (before, during and after childbirth): Classic" PRECAPP pathway
- Patient with integration (in 2023) of the PRECAPP program late in pregnancy (up to 1 month before delivery): PRECAPP "late" pathway
- Vulnerable and precarious patient not followed by PRECAPP but who should have been (maternity course completed in 2023): PRECAPP "non-integration" pathway
Description
Inclusion Criteria:
- Age ≥ 18 years
- Follow-up in 2023 at Gonesse Hospital
- Patient having started her PRECAPP follow-up in 2023, between the 2nd and 5th month of pregnancy and having been accompanied throughout her PRECAPP journey (before, during and after childbirth): Classic" PRECAPP pathway
- Patient with integration (in 2023) of the PRECAPP program late in pregnancy (up to 1 month before delivery): PRECAPP "late" pathway
- Vulnerable and precarious patient not followed by PRECAPP but who should have been (maternity course completed in 2023): PRECAPP "non-integration" pathway
Exclusion Criteria:
- Patient without vulnerability/poverty
- Patient not followed at the CHG in 2023
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
1st stage: preliminary study 4 to 5 PRECAPP files
Construction of an analysis grid including :
Study of 4 to 5 files selected by the PRECAPP team, representing "typical" PRECAPP situations in 2023. This stage will enable us to establish an initial typology and target the files to be studied in subsequent stages. |
|
2nd stage: in-depth analysis of 15 to 20 PRECAPP files
|
|
Step 3: Analysis of 4 to 5 maternity files (not monitored by PRECAPP)
Selection of 4-5 files of precarious and vulnerable women who were not monitored by PRECAPP and who arrived at the maternity hospital without PRECAPP's intervention, in collaboration with the maternity hospital and PRECAPP. Construction of a specific analysis grid (different from the analysis grid for PRECAPP files, including in particular the reasons why patients escaped PRECAPP follow-up). Data collection and in-depth analysis of files (maternity unit and research team) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
demographics
Time Frame: enrollment
|
age, nationality, number of children, family situation
|
enrollment
|
|
clinics
Time Frame: enrollment
|
stage of pregnancy, reason for referral, characterization of vulnerability and precariousness, problems anticipated and avoided, difficulties encountered and overcome
|
enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
follow up
Time Frame: enrollment
|
Nature of support
|
enrollment
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 0087_MATER_PRECAPP
Drug and device information, study documents
product manufactured in and exported from the U.S.
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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