Clinical trial NCT02402855: NAITRE (PreNAtal Care in deprIvaTed enviRonnEment)
Official title: Impact of Conditional Financial Support on Pregnancy Outcomes in Pregnant Women With Low Incomes: Pragmatic Randomized Cluster Trial, With Parallel Arms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Keywords: Couverture Maladie Universelle
Couverture Maladie Universelle-Complémentaire
free health care
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 3787
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurence of complication(s) of pregnancy, wether maternal, fetal or neonatal
timeFrame: Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date.
Secondary outcomes:
measure: Neonatal morbidity, mortality and rate of transfer of the newborn to a neonatal care unit.
timeFrame: Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date.
Other outcomes:
measure: Maternal morbidity, mortality and rate of caesarean sections
timeFrame: Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date.
measure: Number of scheduled consultations attended in agreement with the minimal follow-up recommendations of the Haute Autorité de Santé
timeFrame: Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date.
measure: Interview with a sociologist to evaluate perception of the intervention and evaluation of its perceived impact in follow-up of the pregnancy
timeFrame: About 6 weeks after delivery
measure: Differential cost-effectiveness ratio associated with the financial support compared with the absence of support and expressed in terms of cost per complication avoided
timeFrame: Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date.
Locations:
city: Besancon
country: France
facility: CHRU de BESANCON
city: Brest
country: France
facility: CHRU de BREST
city: Dijon
country: France
facility: CHU de DIJON
city: Kremlin-bicetre
country: France
facility: APHP maternité Kremlin Bicêtre
city: Lille
country: France
facility: CHRU de LILLE
city: Marseille
country: France
facility: APHM Hôpital Nord
city: Paris
country: France
facility: APHP Hopital Robert Debré
city: Saint Etienne
country: France
facility: Chu Saint Etienne
city: Tours
country: France
facility: Chu Tours
Study officials:
References:
citation: 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.