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NAITRE (PreNAtal Care in deprIvaTed enviRonnEment)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 17, 2015
First Posted Date  ICMJE March 30, 2015
Last Update Posted Date November 20, 2020
Actual Study Start Date  ICMJE June 7, 2016
Actual Primary Completion Date September 9, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2015)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2015)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 25, 2015)
  • 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
  • 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. ]
  • 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 ]
  • 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. ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE NAITRE (PreNAtal Care in deprIvaTed enviRonnEment)
Official Title  ICMJE Impact of Conditional Financial Support on Pregnancy Outcomes in Pregnant Women With Low Incomes: Pragmatic Randomized Cluster Trial, With Parallel Arms
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Condition  ICMJE Pregnancy
Intervention  ICMJE
  • 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
  • Other: No intervention
Study Arms  ICMJE
  • Experimental: Group Intervention: Financial support
    Interventions:
    • Other: Delivery of a prepaid payment card
    • Other: Interview with a sociologist
  • Active Comparator: Group Control: no financial support
    Intervention: Other: No intervention
Publications * Bardou M, Crépon 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2020)
3787
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2015)
4000
Actual Study Completion Date  ICMJE September 9, 2020
Actual Primary Completion Date September 9, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02402855
Other Study ID Numbers  ICMJE BARDOU PREPS 2014
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor  ICMJE Centre Hospitalier Universitaire Dijon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP