Clinical trial NCT02275442: Effect of Precariousness in RUral Areas During preGNANCY
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy
Rural Parturient Women
Precarious Situation
EPICES Scale
General Practice
Keywords: EPICES scale
Precarious situation
Rural parturient women
Access to care
Global Initiative for Sentinel E-health Network on Grid
General practice
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Hospital Center of Issoire : Maternity unit
name: PEPRADE label unit EA 4681 : Department of general practice - Clermont-Ferrand AND Unit of Epidemiology, economic health and prevention - C.H.U Clermont-Ferrand
name: Perinatal cares Auvergne network - C.H.U Estaing, Clermont-Ferrand
First posted: 2014-10-27
Enrollment: 190
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: rural parturient women

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: rate for prenatal cares
timeFrame: at 9 months
Secondary outcomes:
measure: antenatal and postnatal cares
timeFrame: at day 1
measure: strategies to overcome difficulties to realize antenatal and postanatal cares
timeFrame: at 2 months
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Philippe VORILHON
role: PRINCIPAL_INVESTIGATOR
References: