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NAITRE (PreNAtal Care in deprIvaTed enviRonnEment)

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ClinicalTrials.gov Identifier: NCT02402855
Recruitment Status : Completed
First Posted : March 30, 2015
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Pregnancy Other: Delivery of a prepaid payment card Other: Interview with a sociologist Other: No intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3787 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Impact of Conditional Financial Support on Pregnancy Outcomes in Pregnant Women With Low Incomes: Pragmatic Randomized Cluster Trial, With Parallel Arms
Actual Study Start Date : June 7, 2016
Actual Primary Completion Date : September 9, 2020
Actual Study Completion Date : September 9, 2020

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



Primary Outcome Measures :
  1. Occurence of complication(s) of pregnancy, wether maternal, fetal or neonatal [ Time Frame: Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date. ]

Secondary Outcome Measures :
  1. Neonatal morbidity, mortality and rate of transfer of the newborn to a neonatal care unit. [ Time Frame: 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 Outcome Measures:
  1. Maternal morbidity, mortality and rate of caesarean sections [ Time Frame: 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: maternal mobidity, mortality and rate og caesarean sections

  2. Number of scheduled consultations attended in agreement with the minimal follow-up recommendations of the Haute Autorité de Santé [ Time Frame: Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date. ]
  3. Interview with a sociologist to evaluate perception of the intervention and evaluation of its perceived impact in follow-up of the pregnancy [ Time Frame: About 6 weeks after delivery ]
  4. Differential cost-effectiveness ratio associated with the financial support compared with the absence of support and expressed in terms of cost per complication avoided [ Time Frame: Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402855


Locations
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France
CHRU de BESANCON
Besancon, France, 25030
CHRU de BREST
Brest, France, 29609
CHU de DIJON
Dijon, France, 21079
APHP maternité Kremlin Bicêtre
Kremlin-bicetre, France, 94270
CHRU de LILLE
Lille, France, 59037
APHM Hôpital Nord
Marseille, France, 13015
APHP Hopital Robert Debré
Paris, France, 75018
Chu Saint Etienne
Saint Etienne, France, 42055
Chu Tours
Tours, France, 37044
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02402855    
Other Study ID Numbers: BARDOU PREPS 2014
First Posted: March 30, 2015    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Keywords provided by Centre Hospitalier Universitaire Dijon:
Couverture Maladie Universelle
Couverture Maladie Universelle-Complémentaire
free health care