NCT03121196

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
615

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 20, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

7 months

First QC Date

April 14, 2017

Last Update Submit

April 14, 2017

Conditions

Keywords

Social deprivationAdverse perinatal outcomes

Outcome Measures

Primary Outcomes (1)

  • Epices score distribution

    Association between EPICES score and the adverse perinatal outcomes will be assessed by quantile regression

    at day 1

Secondary Outcomes (1)

  • Adverse perinatal outcomes

    at day 1

Study Arms (2)

deprived women

Two groups of women will be compared deprived women and non-deprived women

Other: Epices score

non-deprived women

Two groups of women will be compared deprived women and non-deprived women

Other: Epices score

Interventions

Association between EPICES score and the adverse perinatal outcomes will be assessed by quantile regression

deprived womennon-deprived women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pregnant women

You may qualify if:

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

You may not qualify if:

  • Terminations of pregnancy
  • protected women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Diabetes, GestationalHypertensionPremature BirthFetal Growth Retardation

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsFetal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Françoise VENDITELLI

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 20, 2017

Study Start

May 1, 2017

Primary Completion

December 1, 2017

Study Completion

May 1, 2018

Last Updated

April 20, 2017

Record last verified: 2017-04

Locations