PregnancyPRUGNANCYNCT02275442
Effect of Precariousness in RUral Areas During preGNANCY
An observational study of Pregnancy and Rural Parturient Women, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Rural Parturient Women, Precarious Situation
- What is being tested?
- EPICES scale
- How many people
- 190 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2014to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: rural parturient women
Who may be able to join
- Women old enough to procreate. Precariousness: EPICES scale > 30, 17. Live in rural areas (INSEE definition).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Being tested
- EPICES scale
- Keywords
- EPICES scale, Precarious situation, Rural parturient women, Access to care, Global Initiative for Sentinel E-health Network on Grid, General practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPICES scaleOther
What is being measured
The primary outcome is the main question the study is designed to answer.
rate for prenatal cares
Measured: at 9 months
Secondary outcomes (2)
antenatal and postnatal cares
Measured: at day 1
strategies to overcome difficulties to realize antenatal and postanatal cares
questionnaires with open-ended questions to invite further comments
Measured: at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Philippe VORILHON, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275442
- Sponsor's protocol ID
- CHU-0212
- Acronym
- PRUGNANCY
- Status last verified
- Oct 2014
- First submitted
- 3 Oct 2014
- Last updated
- 27 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Precariousness in RUral Areas During preGNANCY
- ClinicalTrials.gov ID
- NCT02275442
- Acronym / sponsor ID
- PRUGNANCY / CHU-0212
- Keywords
- EPICES scale, Precarious situation, Rural parturient women, Access to care, Global Initiative for Sentinel E-health Network on Grid, General practice
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- 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
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 27 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- rural parturient women
Key inclusion criteria (1 listed)
- Women old enough to procreate. Precariousness: EPICES scale > 30, 17. Live in rural areas (INSEE definition).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPICES scale | Other | – |
Primary outcome
rate for prenatal cares
Time frame: at 9 months
2 secondary outcomes
antenatal and postnatal cares
Time frame: at day 1
strategies to overcome difficulties to realize antenatal and postanatal cares
Time frame: at 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe VORILHON principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Rural Parturient Women, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate for prenatal cares (time frame: at 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2014.