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

U

University Hospital, Clermont-Ferrand

Status

Terminated

Conditions

Living in an Isolated Area
Pregnancy

Treatments

Other: Home visitation

Study type

Interventional

Funder types

Other

Identifiers

NCT04823104
PREPS 2019 DEBOST-LEGRAND

Details and patient eligibility

About

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.

Enrollment

105 patients

Sex

Female

Ages

12 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

105 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Lise Laclautre

Data sourced from clinicaltrials.gov

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