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

Not Applicable

Recruiting

• Conditions: Living in an Isolated Area; Pregnancy
• Interventions: Other: Home visitation

• Registration Number: NCT04823104
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-23
• Study First Submitted QC: 2021-03-26
• Study First Posted: 2021-03-30
• Status Verified: 2022-08
• Study Start: 2022-09-01
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-21
• Primary Completion: 2025-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 330

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group with home visitation	Home visitation	pregnant women who are included in this group will be assigned an intervention by home visitation for pregnancy follow-up

Primary Outcome Measures

Name	Time	Method
adequate pregnancy follow-up according to the French recommendations	9 months	number of biological exams of recommended laboratory tests for antenatal care

Secondary Outcome Measures

Name	Time	Method
adverse neonatal outcome	9 months	prematurity, in utero death, small or large for gestational age, transfer in intensive unit
adverse maternal outcome	10 months	gestational hypertension, preeclampsia, gestational diabetes, post-partum hemmorage, maternal death, transfer in intensive unit
economic analyse of the intervention	24 months	cost of equipment, human resources, balanced to income inherent to the project in accordance with the standards of cost budget accounting by insurance perspective.
Adherence to antenatal care consultations of women	9 months	Adherence 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 clinic	9 months	The performance of all of the recommended ultrasounds at the recommended dates and all of the mandatory or recommended laboratory tests for antenatal care

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, Aura, France