NAITRE (PreNAtal Care in deprIvaTed enviRonnEment)
Impact of Conditional Financial Support on Pregnancy Outcomes in Pregnant Women With Low Incomes: Pragmatic Randomized Cluster Trial, With Parallel Arms
1 other identifier
interventional
3,787
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pregnancy
Started Jun 2016
Longer than P75 for not_applicable pregnancy
9 active sites
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
First Submitted
Initial submission to the registry
March 17, 2015
CompletedFirst Posted
Study publicly available on registry
March 30, 2015
CompletedStudy Start
First participant enrolled
June 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2020
CompletedNovember 20, 2020
November 1, 2020
4.3 years
March 17, 2015
November 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurence of complication(s) of pregnancy, wether maternal, fetal or neonatal
Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date.
Secondary Outcomes (1)
Neonatal morbidity, mortality and rate of transfer of the newborn to a neonatal care unit.
Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date.
Other Outcomes (4)
Maternal morbidity, mortality and rate of caesarean sections
Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date.
Number of scheduled consultations attended in agreement with the minimal follow-up recommendations of the Haute Autorité de Santé
Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date.
Interview with a sociologist to evaluate perception of the intervention and evaluation of its perceived impact in follow-up of the pregnancy
About 6 weeks after delivery
- +1 more other outcomes
Study Arms (2)
Group Intervention: Financial support
EXPERIMENTALGroup Control: no financial support
ACTIVE COMPARATORInterventions
Delivery of a prepaid payment card credited according to consultations attended
Eligibility Criteria
You may qualify if:
- Pregnant women
- Age \> 18 years
- st 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
CHRU de BESANCON
Besançon, 25030, France
CHRU de BREST
Brest, 29609, France
CHU de DIJON
Dijon, 21079, France
APHP maternité Kremlin Bicêtre
Le Kremlin-Bicêtre, 94270, France
CHRU de LILLE
Lille, 59037, France
APHM Hôpital Nord
Marseille, 13015, France
APHP Hopital Robert Debré
Paris, 75018, France
Chu Saint Etienne
Saint-Etienne, 42055, France
Chu Tours
Tours, 37044, France
Related Publications (2)
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.
PMID: 36990483DERIVEDBardou 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.
PMID: 29084796DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2015
First Posted
March 30, 2015
Study Start
June 7, 2016
Primary Completion
September 9, 2020
Study Completion
September 9, 2020
Last Updated
November 20, 2020
Record last verified: 2020-11