Gestational DiabetesNCT03121196
Social Deprivation and Pregnancy
An observational study of Gestational Diabetes and High Blood Pressure, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Social deprivation during pregnancy is associated to adverse perinatal outcomes. However, prenatal screening of social deprivation by reliable measurement is not performed. Prevalence of social deprivation is yet underestimated during pregnancy and vulnerable women are not being provided optimal prenatal care. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, High Blood Pressure, Prematurity
- What is being tested?
- Epices score
- How many people
- 615 participants
- Where
- 1 siteFrance
- Study dates
- May 2017to May 2018
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: pregnant women
Who may be able to join
- more than 18 years old
- delivery at 2 maternity hospitals of Clermont-Ferrand area
- fluent command of spoken and written French
Who cannot join
- Terminations of pregnancy
- protected women
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Françoise VENDITELLI
About this study
Social deprivation during pregnancy is associated to adverse perinatal outcomes. However, prenatal screening of social deprivation by reliable measurement is not performed. Prevalence of social deprivation is yet underestimated during pregnancy and vulnerable women are not being provided optimal prenatal care.
Our aim is to validate EPICES score during pregnancy.
Read the detailed description
The process of deprivation was defined first by J. Wrezinski and P. Townsend who also reported that deprivation is the main cause of inequalities in health. Several studies have already shown an association between socioeconomic deprivation and adverse birth outcomes. EPICES score is the only one that measure individual deprivation. The EPICES score should be therefore included systematically in standard follow-up of pregnant women.
Descriptive analysis will assess women's characteristics and prevalence of social deprivation. Two groups of women will be compared deprived women and non-deprived women.
Association between EPICES score and the adverse perinatal outcomes will be assessed by quantile regression.
- Being tested
- Epices score
- Keywords
- Social deprivation, Adverse perinatal outcomes
- Medical subject headings
- Diabetes, Gestational, Hypertension, Premature Birth, Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epices scoreOther
Association between EPICES score and the adverse perinatal outcomes will be assessed by quantile regression
| Study group | Role | What they receive |
|---|---|---|
| deprived women | Two groups of women will be compared deprived women and non-deprived women Receives: Other: Epices score | |
| non-deprived women | Two groups of women will be compared deprived women and non-deprived women Receives: Other: Epices score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epices score distribution
Association between EPICES score and the adverse perinatal outcomes will be assessed by quantile regression
Measured: at day 1
Secondary outcomes (1)
Adverse perinatal outcomes
Association between EPICES score and the adverse perinatal outcomes will be assessed by quantile regression
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2017
- Study startMay 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 615 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Françoise VENDITELLI, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03121196
- Sponsor's protocol ID
- CHU-319
- Other IDs
- 2016-A02076-45
- Status last verified
- Apr 2017
- First submitted
- 14 Apr 2017
- Last updated
- 20 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Deprivation and Pregnancy
- ClinicalTrials.gov ID
- NCT03121196
- Acronym / sponsor ID
- CHU-319
- Keywords
- Social deprivation, Adverse perinatal outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 615 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- May 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 20 Apr 2017 (actual)
- 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.
Social deprivation during pregnancy is associated to adverse perinatal outcomes. However, prenatal screening of social deprivation by reliable measurement is not performed. Prevalence of social deprivation is yet underestimated during pregnancy and vulnerable women are not being provided optimal prenatal care.
Our aim is to validate EPICES score during pregnancy.
Detailed description
The process of deprivation was defined first by J. Wrezinski and P. Townsend who also reported that deprivation is the main cause of inequalities in health. Several studies have already shown an association between socioeconomic deprivation and adverse birth outcomes. EPICES score is the only one that measure individual deprivation. The EPICES score should be therefore included systematically in standard follow-up of pregnant women.
Descriptive analysis will assess women's characteristics and prevalence of social deprivation. Two groups of women will be compared deprived women and non-deprived women.
Association between EPICES score and the adverse perinatal outcomes will be assessed by quantile regression.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deprived women | – | Other: Epices scoreTwo groups of women will be compared deprived women and non-deprived women |
| non-deprived women | – | Other: Epices scoreTwo groups of women will be compared deprived women and non-deprived women |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant women
Key inclusion criteria (3 listed)
- more than 18 years old
- delivery at 2 maternity hospitals of Clermont-Ferrand area
- fluent command of spoken and written French
Key exclusion criteria (2 listed)
- Terminations of pregnancy
- protected women
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 |
|---|---|---|
| Epices scoreAssociation between EPICES score and the adverse perinatal outcomes will be assessed by quantile regression | Other | deprived women, non-deprived women |
Primary outcome
Epices score distribution
Time frame: at day 1
Association between EPICES score and the adverse perinatal outcomes will be assessed by quantile regression
1 secondary outcome
Adverse perinatal outcomes
Time frame: at day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
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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.
Françoise VENDITELLI principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and High Blood Pressure, run by University Hospital, Clermont-Ferrand at 1 site 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epices score distribution (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2017.