Social Deprivation and Pregnancy

Gestational Diabetes Clinical Trial

Official title:

Social Deprivation and Pregnancy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03121196
• Other study ID #: CHU-319
• Secondary ID: 2016-A02076-45
• Status: Not yet recruiting
• Phase: N/A
• First received: April 14, 2017
• Last updated: April 14, 2017
• Start date: May 2017
• Est. completion date: May 2018

Study information

• Verified date: April 2017
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Our aim is to validate EPICES score during pregnancy.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 615
• Est. completion date: May 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Fetal Growth Restriction
• Fetal Growth Retardation
• Gestational Diabetes
• High Blood Pressure
• Hypertension
• Prematurity

Intervention

Other:
• Epices score
Association between EPICES score and the adverse perinatal outcomes will be assessed by quantile regression

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epices score distribution	Association between EPICES score and the adverse perinatal outcomes will be assessed by quantile regression	at day 1
Secondary	Adverse perinatal outcomes	Association between EPICES score and the adverse perinatal outcomes will be assessed by quantile regression	at day 1