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© 2023 Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Introduction

Rural residence appears to be a factor of vulnerability among pregnant women with poor clinical antenatal care. Our principal objective is to assess the impact of an infrastructure for a mobile antenatal care clinic on the completion of antenatal care for women identified as geographically vulnerable in a perinatal network.

Methods and analysis

Controlled cluster-randomised study in two parallel arms comparing an intervention group with an open-label control group. This study will concern the population of pregnant women who must live in one of the municipalities covered by the perinatal network and considered to be an area of geographic vulnerability. The cluster randomisation will take place according to the municipality of residence. The intervention will be the implementation of pregnancy monitoring by a mobile antenatal care clinic. The completion of antenatal care between the intervention and control groups will be a binary criterion: 1 will be attributed to each antenatal care that includes all visits and supplementary examinations. Sample size has been estimated to be 330 at least with an 80% participation rate.

The univariate analyses will compare the follow-up rates (with Fisher’s exact test), and all individual characteristics collected (Fisher’s exact test, Student’s t-test) between the two groups. The multivariate analysis will use a mixed linear model analysis and consider the cluster effect as random; the initial model will include known confounders from the literature, confounders identified in univariate analyses, and the clinically relevant prognostic factors. All of these factors will be taken into account in the model as a fixed effect.

Ethics and dissemination

The Patient Protection Committee North-West II approved this study on 4 February 2021 (IRB 2020-A02247-32). The results will be the subject of scientific communications and publications.

Trial registration number

NCT04823104.

Details

Title
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
Author
Debost-Legrand, Anne 1   VIAFID ORCID Logo  ; Legrand, Guillaume 2 ; Duclos-Médard, Julie 3 ; Thomazet, Juliette 3 ; Pranal, Marine 4   VIAFID ORCID Logo  ; Langlois, Eric 5 ; Mourgues, Charline 6 ; Vendittelli, Françoise 1 

 CHU Clermont-Ferrand, CNRS, Clermont Auvergne INP, Institut Pascal, Université Clermont Auvergne, Clermont-Ferrand, France; Réseau de Santé en Périnatalité d'Auvergne, CHU Clermont-Ferrand, Clermont-Ferrand, France 
 Centre Hospitalier Sainte Marie de Clermont-Ferrand, Association Hospitalière Sainte-Marie, Chamalieres, France 
 Réseau de Santé en Périnatalité d'Auvergne, CHU Clermont-Ferrand, Clermont-Ferrand, France 
 CHU Clermont-Ferrand, CNRS, Clermont Auvergne INP, Institut Pascal, Université Clermont Auvergne, Clermont-Ferrand, France 
 UMR Territoires, AgroparisTech, INRA, Irstea, VetAgro Sup, Universite Clermont Auvergne, Clermont-Ferrand, France 
 Direction de la Recherche Clinique et de l’Innovation, CHU Clermont-Ferrand, Clermont-Ferrand, France 
First page
e060337
Section
Obstetrics and gynaecology
Publication year
2023
Publication date
2023
Publisher
BMJ Publishing Group LTD
e-ISSN
20446055
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
2777798649
Copyright
© 2023 Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/ . Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.