Effect of Oral Prophylactic Measures on the Occurrence of Pre-Eclampsia (OP-PE) in High-Risk Pregnant Women: A Cluster Randomized Controlled Trial - Archive ouverte HAL
Article Dans Une Revue Methods and Protocols Année : 2021

Effect of Oral Prophylactic Measures on the Occurrence of Pre-Eclampsia (OP-PE) in High-Risk Pregnant Women: A Cluster Randomized Controlled Trial

Aida Kanoute
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Jocely Gare
Nicolas Meda
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Stephane Viennot
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Paul Tramini
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Laurie Fraticelli
Florence Carrouel
Denis Bourgeois
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Résumé

Pre-eclampsia (PE), a pregnancy-specific hypertensive disorder, characterized by the development of placental endothelial dysfunction, remains a major source of maternal and perinatal morbidity and mortality, especially in low- and middle-income settings. Periodontal disorders during pregnancy, and particularly periodontal pathogens, may be related to the risk of PE. Standard oral hygiene methods, based mainly on the joint use of toothbrushes and interdental brushes, reduce periodontal inflammatory risk and modulate the dysbiosis of the oral microbiome. The aim of this trial is to compare the PE outcomes in high-risk pregnant women receiving oral prophylactic measures to a control group. This trial is designed as a two-arm, parallel, cluster randomized controlled trial with the antenatal obstetric clinic as the unit of randomization and an allocation ratio of 1:1. The pregnant women will be included at 3 months of pregnancy and will be followed throughout the pregnancy. The primary outcome measure will be the incidence of PE from a baseline during the pregnancy. Secondary outcomes measures will include changes from the baseline in quantification of the pathogenic bacterial load of the interdental microbiota, the severity scores of periodontal indicators, and the incidence of adverse perinatal outcomes. This trial should demonstrate that the implementation of daily oral hygiene reduces oral dysbiosis, the incidence of periodontal disease, and the risk of PE.
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Dates et versions

hal-03334806 , version 1 (05-09-2021)

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Citer

Aida Kanoute, Jocely Gare, Nicolas Meda, Stephane Viennot, Paul Tramini, et al.. Effect of Oral Prophylactic Measures on the Occurrence of Pre-Eclampsia (OP-PE) in High-Risk Pregnant Women: A Cluster Randomized Controlled Trial. Methods and Protocols, 2021, ⟨10.3390/mps4030061⟩. ⟨hal-03334806⟩
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