NAITRE (PreNAtal Care in deprIvaTed enviRonnEment)

NCT ID: NCT02402855

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3787 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-07

Study Completion Date

2020-09-09

Brief Summary

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This study aims to evaluate the impact of financial support on improving the management of prenatal care in pregnant women with low incomes. The judgment criterion is clinically pertinent: complications of pregnancy. This study also aims to evaluate attitudes to this approach through a qualitative survey.

It is planned to include 4000 women distributed into two arms of 2000 each. One group will receive financial support (prepaid payment card credited for each consultation attended according to the scheduled follow-up as recommended by the Haute Autorité de Santé); the other group will not. The management of the pregnancy for both groups will not be modified.

Detailed Description

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Conditions

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Pregnancy

Keywords

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Couverture Maladie Universelle Couverture Maladie Universelle-Complémentaire free health care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Group Intervention: Financial support

Group Type EXPERIMENTAL

Delivery of a prepaid payment card

Intervention Type OTHER

Delivery of a prepaid payment card credited according to consultations attended

Interview with a sociologist

Intervention Type OTHER

For a sub-group of 40 womens

Group Control: no financial support

Group Type ACTIVE_COMPARATOR

No intervention

Intervention Type OTHER

Interventions

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Delivery of a prepaid payment card

Delivery of a prepaid payment card credited according to consultations attended

Intervention Type OTHER

Interview with a sociologist

For a sub-group of 40 womens

Intervention Type OTHER

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant women
* Age \> 18 years
* 1st consultation before the 26th week of amenorrhea
* Recipient of free health care (Couverture Maladie Universelle, Couverture Maladie Universelle-Complémentaire)
* Who have provided written informed consent to take part in the study

Exclusion Criteria

* Persons without national health insurance cover
* Persons unable to understand the information on the study, despite the help of a translator or a person of trust if necessary
* Persons under guardianship
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHRU de BESANCON

Besançon, , France

Site Status

CHRU de BREST

Brest, , France

Site Status

CHU de DIJON

Dijon, , France

Site Status

APHP maternité Kremlin Bicêtre

Le Kremlin-Bicêtre, , France

Site Status

CHRU de LILLE

Lille, , France

Site Status

APHM Hôpital Nord

Marseille, , France

Site Status

APHP Hopital Robert Debré

Paris, , France

Site Status

Chu Saint Etienne

Saint-Etienne, , France

Site Status

Chu Tours

Tours, , France

Site Status

Countries

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France

References

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Bardou M, Meunier-Beillard N, Godard-Marceau A, Deruelle P, Virtos C, Eckman-Lacroix A, Debras E, Schmitz T; NAITRE Study group. Women and health professionals' perspectives on a conditional cash transfer programme to improve pregnancy follow-up: a qualitative analysis of the NAITRE randomised controlled study. BMJ Open. 2023 Mar 29;13(3):e067066. doi: 10.1136/bmjopen-2022-067066.

Reference Type DERIVED
PMID: 36990483 (View on PubMed)

Bardou M, Crepon B, Bertaux AC, Godard-Marceaux A, Eckman-Lacroix A, Thellier E, Falchier F, Deruelle P, Doret M, Carcopino-Tusoli X, Schmitz T, Barjat T, Morin M, Perrotin F, Hatem G, Deneux-Tharaux C, Fournel I, Laforet L, Meunier-Beillard N, Duflo E, Le Ray I; NAITRE Study Group. NAITRE study on the impact of conditional cash transfer on poor pregnancy outcomes in underprivileged women: protocol for a nationwide pragmatic cluster-randomised superiority clinical trial in France. BMJ Open. 2017 Oct 30;7(10):e017321. doi: 10.1136/bmjopen-2017-017321.

Reference Type DERIVED
PMID: 29084796 (View on PubMed)

Other Identifiers

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BARDOU PREPS 2014

Identifier Type: -

Identifier Source: org_study_id