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

Pregnancy Clinical Trial

— OPTI'SOINS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04823104
• Other study ID #: PREPS 2019 DEBOST-LEGRAND
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: April 1, 2026

Study information

• Verified date: August 2022
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise Laclautre
• Phone: 04 73 75 11 95
• Email: promo_interne_drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Living in an Isolated Area
• Pregnancy

Intervention

Other:
• Home visitation
Home visitation for pregnancy follow-up

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand	Aura

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	adequate pregnancy follow-up according to the French recommendations	number of biological exams of recommended laboratory tests for antenatal care	9 months
Secondary	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
Secondary	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
Secondary	adverse neonatal outcome	prematurity, in utero death, small or large for gestational age, transfer in intensive unit	9 months
Secondary	adverse maternal outcome	gestational hypertension, preeclampsia, gestational diabetes, post-partum hemmorage, maternal death, transfer in intensive unit	10 months
Secondary	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