Optimizing Access to Care During Pregnancy in Rural Areas in a Perinatal Health Network (OPTI'SOINS)

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

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.

Study Overview

• Status: Terminated
• Conditions: Pregnancy; Living in an Isolated Area
• Intervention / Treatment: Other: Home visitation

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aura
    • Clermont-Ferrand, Aura, France, 63000
      • CHU Clermont-Ferrand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
adverse maternal outcome	gestational hypertension, preeclampsia, gestational diabetes, post-partum hemmorage, maternal death, transfer in intensive unit	10 months
adverse neonatal outcome	prematurity, in utero death, small or large for gestational age, transfer in intensive unit	9 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
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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): March 5, 2025
• Study Completion (Actual): March 5, 2025

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 26, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy; Home visitation; Isolated geographic area
• Other Study ID Numbers: PREPS 2019 DEBOST-LEGRAND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No