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

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ClinicalTrials.gov Identifier: NCT04823104
Recruitment Status : Not yet recruiting
First Posted : March 30, 2021
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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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.


Condition or disease Intervention/treatment Phase
Pregnancy Living in an Isolated Area Other: Home visitation Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Optimizing Access to Care During Pregnancy in Rural Areas in a Perinatal Health
Estimated Study Start Date : January 1, 2022
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. adequate pregnancy follow-up according to the French recommendations [ Time Frame: 9 months ]
    number of consultations

  2. adequate pregnancy follow-up according to the French recommendations [ Time Frame: 9 months ]
    number of ultrasound exams

  3. adequate pregnancy follow-up according to the French recommendations [ Time Frame: 9 months ]
    number of biological exams


Secondary Outcome Measures :
  1. adverse maternal outcome [ Time Frame: 10 months ]
    gestational hypertension, gestational diabetes, post-partum hemmorage, maternal death, transfer in intensive unit

  2. adverse neonatal outcome [ Time Frame: 9 months ]
    prematurity, in utero death, small or large for gestational age, transfer in intensive unit

  3. economic analyse of the intervention [ Time Frame: 24 months ]
    cost of equipment, human resources, balanced to income inherent to the project in accordance with the standards of cost budget accounting.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women who live in a specific geographic area

Exclusion Criteria:

  • Pregnant women who live outside the specific geographic area
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04823104


Contacts
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Contact: Lise Laclautre 04 73 75 11 95 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, Aura, France, 63000
Contact: Lise laclautre    04 73 75 11 95    promo_interne_drci@chu-clermontferrand.fr   
Principal Investigator: Anne LEGRAND         
Sub-Investigator: Marine PRANAL         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
More Information
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT04823104    
Other Study ID Numbers: PREPS 2019 DEBOST-LEGRAND
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Pregnancy
Home visitation
Isolated geographic area