NAITRE (PreNAtal Care in deprIvaTed enviRonnEment)

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Conditional Financial Support on Pregnancy Outcomes in Pregnant Women With Low Incomes: Pragmatic Randomized Cluster Trial, With Parallel Arms

Conditions
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Pregnancy

Intervention / Treatment
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* Other: Delivery of a prepaid payment card
* Other: Interview with a sociologist
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Couverture Maladie Universelle, Couverture Maladie Universelle-Complémentaire, free health care