NAITRE (PreNAtal Care in deprIvaTed enviRonnEment)

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Other: Delivery of a prepaid payment card; Other: No intervention; Other: Interview with a sociologist

• Registration Number: NCT02402855
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-17
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-30
• Study Start: 2016-06-07
• Primary Completion: 2020-09-09
• Study Completion: 2020-09-09
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 3787

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group Intervention: Financial support	Delivery of a prepaid payment card	-
Group Control: no financial support	No intervention	-
Group Intervention: Financial support	Interview with a sociologist	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.	A composite outcome measure consisting of multiple measures: neonatal morbidity, mortality and rate of tranfer of the newborn to a neonatal care unit

Trial Locations

Locations (9)

APHP maternité Kremlin Bicêtre; 🇫🇷 Kremlin-bicetre, France

CHU de DIJON; 🇫🇷 Dijon, France

APHP Hopital Robert Debré; 🇫🇷 Paris, France

CHRU de BESANCON; 🇫🇷 Besancon, France

CHRU de BREST; 🇫🇷 Brest, France

CHRU de LILLE; 🇫🇷 Lille, France

APHM Hôpital Nord; 🇫🇷 Marseille, France

Chu Saint Etienne; 🇫🇷 Saint Etienne, France

Chu Tours; 🇫🇷 Tours, France