Effect of Precariousness in RUral Areas During preGNANCY

Pregnancy Clinical Trial

— PRUGNANCY  

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02275442
• Other study ID #: CHU-0212
• Status: Active, not recruiting
• Phase: N/A
• First received: October 3, 2014
• Last updated: October 23, 2014
• Start date: September 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2014
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 190
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• EPICES Scale
• General Practice
• Precarious Situation
• Pregnancy
• Rural Parturient Women

Intervention

Other:
• EPICES scale

Locations

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

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate for prenatal cares		at 9 months	No
Secondary	antenatal and postnatal cares		at day 1	No
Secondary	strategies to overcome difficulties to realize antenatal and postanatal cares	questionnaires with open-ended questions to invite further comments	at 2 months	No