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Clinical Trials/NCT04823104
NCT04823104
Terminated
Not Applicable

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

University Hospital, Clermont-Ferrand1 site in 1 country105 target enrollmentSeptember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
105
Locations
1
Primary Endpoint
adequate pregnancy follow-up according to the French recommendations
Status
Terminated
Last Updated
8 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2022
End Date
March 5, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

adequate pregnancy follow-up according to the French recommendations

Time Frame: 9 months

number of biological exams of recommended laboratory tests for antenatal care

Secondary Outcomes

  • adverse neonatal outcome(9 months)
  • adverse maternal outcome(10 months)
  • economic analyse of the intervention(24 months)
  • Adherence to antenatal care consultations of women(9 months)
  • Adherence to antenatal care complementary exams of women by the mobile antenatal care clinic(9 months)

Study Sites (1)

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