Optimizing Access to Care During Pregnancy in Rural Areas in a Perinatal Health Network

Study Overview
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Brief Summary
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Pregnant women who live in rural area have fewer prenatal consultations. It has been demonstrated that maternal and neonatal morbidity and mortality increase if time travel to a maternity ward is longer than 30 min. Home visitation in isolated area may improve prenatal follow-up as it gives full access to women to health care professionals as well as biological and ultrasound exams without travelling. Our aim is to assess the impact of home visitation on prenatal follow-up as compared to prenatal follow-up in maternity ward and in primary care. Isolated areas will be randomized, for women living in areas included in the intervention group, home visitations will be planned for prenatal follow-up. Ultrasound screening as well as blood exams will be performed during home visitations. For women living in control areas, they will be free to choose prenatal follow-up modalities.

Official Title
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Optimizing Access to Care During Pregnancy in Rural Areas in a Perinatal Health

Conditions
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Pregnancy, Living in an Isolated Area

Intervention / Treatment
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* Other: Home visitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At the first antenatal consultation, confirming the pregnancy. Pregnant women who live in an area of geographic vulnerability covered by a perinatal network The women must be informed about the study, understand, read, and speak French, and must be able to consent to participate in medical research Exclusion Criteria: Pregnant women who live outside an area of geographic vulnerability covered by a perinatal network Women who give birth in a maternity ward outside Auvergne Women from another region giving birth in a maternity ward in Auvergne

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group with home visitation<br>pregnant women who are included in this group will be assigned an intervention by home visitation for pregnancy follow-up | Other: Home visitation<br>* Home visitation for pregnancy follow-up<br>|
| No Intervention: control group without home visitation<br>pregnant women will be free to choose their pregnancy follow-up without home visitation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adequate pregnancy follow-up according to the French recommendations | number of consultations, In all, 8 consultations should take place in a pregnancy that goes to term | 9 months | 
| adequate pregnancy follow-up according to the French recommendations | number of ultrasound exams, Three systematic or screening ultrasound examinations, one per trimester, are recommended | 9 months | 
| adequate pregnancy follow-up according to the French recommendations | number of biological exams of recommended laboratory tests for antenatal care | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to antenatal care consultations of women | Adherence to the applicable French regulations concerning the term and number of consultations that must be performed until delivery | 9 months | 
| Adherence to antenatal care complementary exams of women by the mobile antenatal care clinic | The performance of all of the recommended ultrasounds at the recommended dates and all of the mandatory or recommended laboratory tests for antenatal care | 9 months | 
| adverse neonatal outcome | prematurity, in utero death, small or large for gestational age, transfer in intensive unit | 9 months | 
| adverse maternal outcome | gestational hypertension, preeclampsia, gestational diabetes, post-partum hemmorage, maternal death, transfer in intensive unit | 10 months | 
| economic analyse of the intervention | cost of equipment, human resources, balanced to income inherent to the project in accordance with the standards of cost budget accounting by insurance perspective. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Home visitation, Isolated geographic area