NCT02275442

Brief Summary

The link between precarious situations and health conditions are more described in previous study. Precarious situations are more frequent and complex especially in rural areas. There are recognized like a risk factor of complications during pregnancy and delivery. It's necessary to describe antenatal cares for rural women in precarious situations to prevent those situations, to understand their difficulties in order to reduce inequalities and health spending. The aim of the PRUGNANCY study is to understand the difficulties of rural parturient women and the strategies developed to overcome them. Recognized earlier precarious situations and valorized General Practitioners and restore them to the follow-up or parturient women.

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
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2014

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 27, 2014

Status Verified

October 1, 2014

Enrollment Period

1.1 years

First QC Date

October 3, 2014

Last Update Submit

October 23, 2014

Conditions

Keywords

EPICES scalePrecarious situationRural parturient womenAccess to careGlobal Initiative for Sentinel E-health Network on GridGeneral practice

Outcome Measures

Primary Outcomes (1)

  • rate for prenatal cares

    at 9 months

Secondary Outcomes (2)

  • antenatal and postnatal cares

    at day 1

  • strategies to overcome difficulties to realize antenatal and postanatal cares

    at 2 months

Interventions

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

rural parturient women

You may qualify if:

  • Women old enough to procreate. Precariousness: EPICES scale \> 30, 17. Live in rural areas (INSEE definition).

You may not qualify if:

  • To be unable to answer the questionnaire: intellectual disability or no French speaker or illiterates.
  • EPICES scale not completed. Women who gave birth to a stillborn child. Medical interruption of pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Study Officials

  • Philippe VORILHON

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2014

First Posted

October 27, 2014

Study Start

September 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 27, 2014

Record last verified: 2014-10

Locations