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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Other: No intervention; Other: Delivery of a prepaid payment card; Other: Interview with a sociologist

• Study Type: Interventional
• Enrollment (Actual): 3787
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besancon, France, 25030
    • CHRU De Besancon
  • Brest, France, 29609
    • CHRU de Brest
  • Dijon, France, 21079
    • CHU de DIJON
  • Kremlin-bicetre, France, 94270
    • APHP maternité Kremlin Bicêtre
  • Lille, France, 59037
    • Chru de Lille
  • Marseille, France, 13015
    • APHM Hopital Nord
  • Paris, France, 75018
    • APHP Hopital Robert Debré
  • Saint Etienne, France, 42055
    • Chu Saint Etienne
  • Tours, France, 37044
    • CHU Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Intervention: Financial support	Other: Delivery of a prepaid payment card; Delivery of a prepaid payment card credited according to consultations attended; Other: Interview with a sociologist; For a sub-group of 40 womens
Active Comparator: Group Control: no financial support	Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal morbidity, mortality and rate of transfer of the newborn to a neonatal care unit.	A composite outcome measure consisting of multiple measures: neonatal morbidity, mortality and rate of tranfer 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal morbidity, mortality and rate of caesarean sections	A composite outcome measure consisting of multiple measures: maternal mobidity, mortality and rate og 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
Differential cost-effectiveness ratio associated with the financial support compared with the absence of support and expressed in terms of cost per complication avoided		Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date.

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2016
• Primary Completion (Actual): September 9, 2020
• Study Completion (Actual): September 9, 2020

Study Registration Dates

• First Submitted: March 17, 2015
• First Submitted That Met QC Criteria: March 25, 2015
• First Posted (Estimate): March 30, 2015

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 18, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Couverture Maladie Universelle; Couverture Maladie Universelle-Complémentaire; free health care
• Other Study ID Numbers: BARDOU PREPS 2014