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Completed

NCT Number: NCT02402855

NAITRE (PreNAtal Care in deprIvaTed enviRonnEment)

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.

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Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de BESANCON, Besançon, France

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delivery of a prepaid payment card

Other

Delivery of a prepaid payment card credited according to consultations attended

Interview with a sociologist

Other

For a sub-group of 40 womens

No intervention

Other

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 30, 2015
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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