Effect of Precariousness in RUral Areas During preGNANCY (PRUGNANCY)

October 23, 2014 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It's a multicenter prospective observational study with a quali-quantitative method. This study involved three maternities in Auvergne region (Issoire, Thiers, Saint-Flour). Precarious women living in rural areas are included. They will be followed during a period of two months after childbirth. The main assessment criterion is the adequation rate between antenatal care for those women and the HAS recommendation's.

The amount necessary to highlight a significant difference is 190 patients (IC 95% [0.429 - 0.571] ; risk = 5 % ; Adequation rate = 50 % ; lost to follow-up rate = 10 % ; deprivation rate = 27 %).

The secondary criteria of judgment are the reasons for not realized antenatal and postnatal cares, the difficulties of realized antenatal and postnatal cares, the strategies developed to overcome them, the term and health status of the child birth (Apgar score, birth weight), the health status of the child birth and his mother during the two post-partum months (HAS recommendation's).

Study Type

Observational

Enrollment (Anticipated)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Chu Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

rural parturient women

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate for prenatal cares
Time Frame: at 9 months
at 9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
antenatal and postnatal cares
Time Frame: at day 1
at day 1
strategies to overcome difficulties to realize antenatal and postanatal cares
Time Frame: at 2 months
questionnaires with open-ended questions to invite further comments
at 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

Hospital Center of Issoire : Maternity unit
PEPRADE label unit EA 4681 : Department of general practice - Clermont-Ferrand AND Unit of Epidemiology, economic health and prevention - C.H.U Clermont-Ferrand
Perinatal cares Auvergne network - C.H.U Estaing, Clermont-Ferrand

Investigators

  • Principal Investigator: Philippe VORILHON, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

October 3, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Estimate)

October 27, 2014

Last Update Submitted That Met QC Criteria

October 23, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHU-0212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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