PregnancyNCT02402855
NAITRE (PreNAtal Care in deprIvaTed enviRonnEment)
A study testing Delivery of a prepaid payment card and Interview with a sociologist in people with Pregnancy, run by Centre Hospitalier Universitaire Dijon at 9 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Delivery of a prepaid payment card and Interview with a sociologist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,787 participants
- Where
- 9 sitesFrance
- Study dates
- 7 Jun 2016to 9 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHRU de BESANCON
Besançon, 25030
CHRU de BREST
Brest, 29609
CHU de DIJON
Dijon, 21079
APHP maternité Kremlin Bicêtre
Le Kremlin-Bicêtre, 94270
CHRU de LILLE
Lille, 59037
APHM Hôpital Nord
Marseille, 13015
APHP Hopital Robert Debré
Paris, 75018
Chu Saint Etienne
Saint-Etienne, 42055
Chu Tours
Tours, 37044
About this study
Official title: Impact of Conditional Financial Support on Pregnancy Outcomes in Pregnant Women With Low Incomes: Pragmatic Randomized Cluster Trial, With Parallel Arms
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.
- Conditions
- Pregnancy
- Being tested
- Delivery of a prepaid payment card, Interview with a sociologist, No intervention
- Keywords
- Couverture Maladie Universelle, Couverture Maladie Universelle-Complémentaire, free health care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delivery of a prepaid payment cardOther
Delivery of a prepaid payment card credited according to consultations attended
Interview with a sociologistOther
For a sub-group of 40 womens
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Group Intervention: Financial support | Experimental | Not described Receives: Other: Delivery of a prepaid payment card; Other: Interview with a sociologist |
| Group Control: no financial support | Active comparator | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of complication(s) of pregnancy, wether maternal, fetal or neonatal
Measured: 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.
A composite outcome measure consisting of multiple measures: neonatal morbidity, mortality and rate of tranfer of the newborn to a neonatal care unit
Measured: Participants will be followed for the duration of hospital stay and for a maximum of one month after the term date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study start7 Jun 2016
- Primary completion9 Sep 2020
- Study completion9 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,787 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402855
- Sponsor's protocol ID
- BARDOU PREPS 2014
- Status last verified
- Nov 2020
- First submitted
- 17 Mar 2015
- Last updated
- 20 Nov 2020
- Results posted
- No
Publications
Bardou M, Meunier-Beillard N, Godard-Marceau A, Deruelle P, Virtos C, Eckman-Lacroix A, Debras E, Schmitz T; NAITRE Study group. Women and health professionals' perspectives on a conditional cash transfer programme to improve pregnancy follow-up: a qualitative analysis of the NAITRE randomised controlled study. BMJ Open. 2023 Mar 29;13(3):e067066. doi: 10.1136/bmjopen-2022-067066.
PubMed 36990483Bardou M, Crepon 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.
PubMed 29084796
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Conditional Financial Support on Pregnancy Outcomes in Pregnant Women With Low Incomes: Pragmatic Randomized Cluster Trial, With Parallel Arms
- ClinicalTrials.gov ID
- NCT02402855
- Acronym / sponsor ID
- BARDOU PREPS 2014
- Conditions
- Pregnancy
- Keywords
- Couverture Maladie Universelle, Couverture Maladie Universelle-Complémentaire, free health care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,787 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 7 Jun 2016 (actual)
- Primary completion
- 9 Sep 2020 (actual)
- Study completion
- 9 Sep 2020 (actual)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Intervention: Financial support | Experimental | Other: Delivery of a prepaid payment card, Other: Interview with a sociologist |
| Group Control: no financial support | Active comparator | Other: No intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delivery of a prepaid payment cardDelivery of a prepaid payment card credited according to consultations attended | Other | Group Intervention: Financial support |
| Interview with a sociologistFor a sub-group of 40 womens | Other | Group Intervention: Financial support |
| No intervention | Other | Group Control: no financial support |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Derived from this study: PubMed 36990483Bardou M, Meunier-Beillard N, Godard-Marceau A, Deruelle P, Virtos C, Eckman-Lacroix A, Debras E, Schmitz T; NAITRE Study group. Women and health professionals' perspectives on a conditional cash transfer programme to improve pregnancy follow-up: a qualitative analysis of the NAITRE randomised controlled study. BMJ Open. 2023 Mar 29;13(3):e067066. doi: 10.1136/bmjopen-2022-067066.
- Derived from this study: PubMed 29084796Bardou M, Crepon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delivery of a prepaid payment card and Interview with a sociologist in people with Pregnancy, run by Centre Hospitalier Universitaire Dijon at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02402855, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.