Here is the design of a clinical trial:

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

Included conditions:
- Pregnancy
- Living in an Isolated Area

Study Armgroups:
- {'label': 'Intervention group with home visitation', 'type': 'EXPERIMENTAL', 'description': 'pregnant women who are included in this group will be assigned an intervention by home visitation for pregnancy follow-up', 'interventionNames': ['Other: Home visitation']}
- {'label': 'control group without home visitation', 'type': 'NO_INTERVENTION', 'description': 'pregnant women will be free to choose their pregnancy follow-up without home visitation'}

Interventions:
- {'type': 'OTHER', 'name': 'Home visitation', 'description': 'Home visitation for pregnancy follow-up', 'armGroupLabels': ['Intervention group with home visitation']}

Primary Outcomes:
- {'measure': 'adequate pregnancy follow-up according to the French recommendations', 'description': 'number of consultations, In all, 8 consultations should take place in a pregnancy that goes to term', 'timeFrame': '9 months'}
- {'measure': 'adequate pregnancy follow-up according to the French recommendations', 'description': 'number of ultrasound exams, Three systematic or screening ultrasound examinations, one per trimester, are recommended', 'timeFrame': '9 months'}
- {'measure': 'adequate pregnancy follow-up according to the French recommendations', 'description': 'number of biological exams of recommended laboratory tests for antenatal care', 'timeFrame': '9 months'}

Please estimate the sample size based on the assumption: 
An alpha risk of 5%, a power of 90%, and a participation rate of 80% are assumed. The level of correlation of behaviors in the same cluster ranges from 0.1 to 0.5.
Sample size calculation
        According to the national perinatal survey, almost 20% of women have not had the eight antenatal consultations recommended.23 According to the PRECare study, 50.7% of women did not receive adequate antenatal care, that is, care that corresponds to the HAS guidelines.24 The objective of the mobile antenatal care clinic is to improve antenatal care so that it meets the national guidelines. Considering the method of randomisation chosen, two indicators must be taken into account: the inflation factor, specific to the cluster, and the level of correlation of the behaviours of subjects in the same cluster. The perinatal health network data suggest that the mean number of women a year who could be included in a cluster is 2.5. Extrapolating from the literature involving pregnant women in cluster-randomised trials, the level of correlation of behaviours ranges from 0.1 to 0.5.25
        For an alpha risk of 5%, a power of 90% and a success rate for the primary objective of 85% for the intervention group and 70% for the control group, we calculated the number of subjects necessary by considering three correlation coefficient values: 0.1, 0.2 and 0.5. The number of subjects necessary thus ranges between 217 and 330 for an 80% participation rate. Considering previous data in the perinatal health network 300â400 pregnancies occur each year in the municipalities include in the study. Thus, the sample size can be reached considering the time of the study. As it is a new intervention, participation rate may be less than expected, however as the mobile clinic will be as close as possible to womenâs living place, access to healthcare will be easier for them.