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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04823104
Acronym
OPTI'SOINS
Enrollment
105
Registered
2021-03-30
Start date
2022-09-01
Completion date
2025-03-05
Last updated
2025-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Living in an Isolated Area, Pregnancy

Keywords

Pregnancy, Home visitation, Isolated geographic area

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.

Interventions

Home visitation for pregnancy follow-up

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
12 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
adequate pregnancy follow-up according to the French recommendations9 monthsnumber of consultations, In all, 8 consultations should take place in a pregnancy that goes to term

Secondary

MeasureTime frameDescription
Adherence to antenatal care consultations of women9 monthsAdherence to the applicable French regulations concerning the term and number of consultations that must be performed until delivery
Adherence to antenatal care complementary exams of women by the mobile antenatal care clinic9 monthsThe performance of all of the recommended ultrasounds at the recommended dates and all of the mandatory or recommended laboratory tests for antenatal care
adverse neonatal outcome9 monthsprematurity, in utero death, small or large for gestational age, transfer in intensive unit
adverse maternal outcome10 monthsgestational hypertension, preeclampsia, gestational diabetes, post-partum hemmorage, maternal death, transfer in intensive unit
economic analyse of the intervention24 monthscost of equipment, human resources, balanced to income inherent to the project in accordance with the standards of cost budget accounting by insurance perspective.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 6, 2026