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Social Deprivation and Pregnancy

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: NCT03121196
Recruitment Status : Unknown
Verified April 2017 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
First Posted : April 20, 2017
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief 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.

Our aim is to validate EPICES score during pregnancy.


Condition or disease Intervention/treatment
Gestational Diabetes High Blood Pressure Prematurity Fetal Growth Restriction Other: Epices score

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.

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Study Type : Observational
Estimated Enrollment : 615 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Social Deprivation and Pregnancy
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
deprived women
Two groups of women will be compared deprived women and non-deprived women
Other: Epices score
Association between EPICES score and the adverse perinatal outcomes will be assessed by quantile regression

non-deprived women
Two groups of women will be compared deprived women and non-deprived women
Other: Epices score
Association between EPICES score and the adverse perinatal outcomes will be assessed by quantile regression




Primary Outcome Measures :
  1. Epices score distribution [ Time Frame: at day 1 ]
    Association between EPICES score and the adverse perinatal outcomes will be assessed by quantile regression


Secondary Outcome Measures :
  1. Adverse perinatal outcomes [ Time Frame: at day 1 ]
    Association between EPICES score and the adverse perinatal outcomes will be assessed by quantile regression



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
pregnant women
Criteria

Inclusion Criteria:

  • more than 18 years old
  • delivery at 2 maternity hospitals of Clermont-Ferrand area
  • fluent command of spoken and written French

Exclusion Criteria:

  • Terminations of pregnancy
  • protected women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03121196


Contacts
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Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Françoise VENDITELLI         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Françoise VENDITELLI University Hospital, Clermont-Ferrand
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03121196    
Other Study ID Numbers: CHU-319
2016-A02076-45 ( Other Identifier: 2016-A02076-45 )
First Posted: April 20, 2017    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Social deprivation
Adverse perinatal outcomes
Additional relevant MeSH terms:
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Diabetes, Gestational
Fetal Growth Retardation
Hypertension
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Fetal Diseases
Growth Disorders
Pathologic Processes