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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02402855
Enrollment
3787
Registered
2015-03-30
Start date
2016-06-07
Completion date
2020-09-09
Last updated
2020-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Couverture Maladie Universelle, Couverture Maladie Universelle-Complémentaire, free health care

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.

Interventions

OTHERDelivery of a prepaid payment card

Delivery of a prepaid payment card credited according to consultations attended

For a sub-group of 40 womens

OTHERNo intervention

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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

Design outcomes

Primary

MeasureTime frame
Occurence of complication(s) of pregnancy, wether maternal, fetal or neonatalParticipants will be followed for the duration of hospital stay and for a maximum of one month after the term date.

Secondary

MeasureTime frameDescription
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

Other

MeasureTime frameDescription
Maternal morbidity, mortality and rate of caesarean sectionsParticipants 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: maternal mobidity, mortality and rate og caesarean sections
Number of scheduled consultations attended in agreement with the minimal follow-up recommendations of the Haute Autorité de SantéParticipants 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 pregnancyAbout 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 avoidedParticipants will be followed for the duration of hospital stay and for a maximum of one month after the term date.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026