NCT04823104

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2025

Completed
Last Updated

August 12, 2025

Status Verified

August 1, 2025

Enrollment Period

2.5 years

First QC Date

March 23, 2021

Last Update Submit

August 7, 2025

Conditions

PregnancyLiving in an Isolated Area

Keywords

PregnancyHome visitationIsolated geographic area

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (5)

  • Adherence to antenatal care consultations of women

    9 months

  • Adherence to antenatal care complementary exams of women by the mobile antenatal care clinic

    9 months

  • adverse neonatal outcome

    9 months

  • adverse maternal outcome

    10 months

  • economic analyse of the intervention

    24 months

Study Arms (2)

Intervention group with home visitation

EXPERIMENTAL

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

Other: Home visitation

control group without home visitation

NO INTERVENTION

pregnant women will be free to choose their pregnancy follow-up without home visitation

Interventions

Home visitationOTHER

Home visitation for pregnancy follow-up

Intervention group with home visitation

Eligibility Criteria

Age12 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, AURA, 63000, France

Location

Related Publications (1)

  • Debost-Legrand A, Legrand G, Duclos-Medard J, Thomazet J, Pranal M, Langlois E, Mourgues C, Vendittelli F. Opti'care protocol: a randomised control trial to evaluate the impact of a mobile antenatal care clinic in isolated rural areas on prenatal follow-up. BMJ Open. 2023 Feb 16;13(2):e060337. doi: 10.1136/bmjopen-2021-060337.

    PMID: 36797021DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 30, 2021

Study Start

September 1, 2022

Primary Completion

March 5, 2025

Study Completion

March 5, 2025

Last Updated

August 12, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)