PregnancyOPTI'SOINSNCT04823104
Optimizing Access to Care During Pregnancy in Rural Areas in a Perinatal Health Network
A study testing Home visitation in people with Pregnancy and Living in an Isolated Area, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 12 to 50 years, women only
- Conditions the study is for
- Pregnancy, Living in an Isolated Area
- What is being tested?
- Home visitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 5 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Access to Care During Pregnancy in Rural Areas in a Perinatal Health
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.
Read more
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.
- Conditions
- Pregnancy, Living in an Isolated Area
- Being tested
- Home visitation
- Keywords
- Pregnancy, Home visitation, Isolated geographic area
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home visitationOther
Home visitation for pregnancy follow-up
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Home visitation |
| control group without home visitation | No intervention | pregnant women will be free to choose their pregnancy follow-up without home visitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 9 months
adequate pregnancy follow-up according to the French recommendations
number of biological exams of recommended laboratory tests for antenatal care
Measured: 9 months
Secondary outcomes (5)
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
Measured: 9 months
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
Measured: 9 months
adverse neonatal outcome
prematurity, in utero death, small or large for gestational age, transfer in intensive unit
Measured: 9 months
adverse maternal outcome
gestational hypertension, preeclampsia, gestational diabetes, post-partum hemmorage, maternal death, transfer in intensive unit
Measured: 10 months
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start1 Sep 2022
- Primary completion5 Mar 2025
- Study completion5 Mar 2025
Why it stopped: Due to recruitment and implementation difficulties, the study was stopped prematurely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823104
- Sponsor's protocol ID
- PREPS 2019 DEBOST-LEGRAND
- Acronym
- OPTI'SOINS
- Status last verified
- Aug 2025
- First submitted
- 23 Mar 2021
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36797021
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Access to Care During Pregnancy in Rural Areas in a Perinatal Health
- ClinicalTrials.gov ID
- NCT04823104
- Acronym / sponsor ID
- OPTI'SOINS / PREPS 2019 DEBOST-LEGRAND
- Conditions
- Pregnancy, Living in an Isolated Area
- Keywords
- Pregnancy, Home visitation, Isolated geographic area
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to recruitment and implementation difficulties, the study was stopped prematurely
- Enrolment
- 105 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group with home visitation | Experimental | Other: Home visitationpregnant women who are included in this group will be assigned an intervention by home visitation for pregnancy follow-up |
| control group without home visitation | No intervention | –pregnant women will be free to choose their pregnancy follow-up without home visitation |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home visitationHome visitation for pregnancy follow-up | Other | Intervention group with home visitation |
Primary outcome
adequate pregnancy follow-up according to the French recommendations
Time frame: 9 months
number of consultations, In all, 8 consultations should take place in a pregnancy that goes to term
adequate pregnancy follow-up according to the French recommendations
Time frame: 9 months
number of ultrasound exams, Three systematic or screening ultrasound examinations, one per trimester, are recommended
adequate pregnancy follow-up according to the French recommendations
Time frame: 9 months
number of biological exams of recommended laboratory tests for antenatal care
5 secondary outcomes
Adherence to antenatal care consultations of women
Time frame: 9 months
Adherence to antenatal care complementary exams of women by the mobile antenatal care clinic
Time frame: 9 months
adverse neonatal outcome
Time frame: 9 months
adverse maternal outcome
Time frame: 10 months
economic analyse of the intervention
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Due to recruitment and implementation difficulties, the study was stopped prematurely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Derived from this study: PubMed 36797021Debost-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home visitation in people with Pregnancy and Living in an Isolated Area, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to recruitment and implementation difficulties, the study was stopped prematurely). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adequate pregnancy follow-up according to the French recommendations (time frame: 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04823104, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.