NAITRE (PreNAtal Care in deprIvaTed enviRonnEment)

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402855
• Other study ID #: BARDOU PREPS 2014
• Status: Completed
• Phase: N/A
• Start date: June 7, 2016
• Est. completion date: September 9, 2020

Study information

• Verified date: November 2020
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3787
• Est. completion date: September 9, 2020
• Est. primary completion date: September 9, 2020
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Other:
• Delivery of a prepaid payment card
Delivery of a prepaid payment card credited according to consultations attended
• Interview with a sociologist
For a sub-group of 40 womens
• No intervention

Locations

Country	Name	City	State
France	CHRU de BESANCON	Besancon
France	CHRU de BREST	Brest
France	CHU de DIJON	Dijon
France	APHP maternité Kremlin Bicêtre	Kremlin-bicetre
France	CHRU de LILLE	Lille
France	APHM Hôpital Nord	Marseille
France	APHP Hopital Robert Debré	Paris
France	Chu Saint Etienne	Saint Etienne
France	Chu Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maternal morbidity, mortality and rate of caesarean sections	A composite outcome measure consisting of multiple measures: maternal mobidity, mortality and rate og caesarean sections	Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date.
Other	Number of scheduled consultations attended in agreement with the minimal follow-up recommendations of the Haute Autorité de Santé		Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date.
Other	Interview with a sociologist to evaluate perception of the intervention and evaluation of its perceived impact in follow-up of the pregnancy		About 6 weeks after delivery
Other	Differential cost-effectiveness ratio associated with the financial support compared with the absence of support and expressed in terms of cost per complication avoided		Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date.
Primary	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	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.