CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 330 enrolled
Drug / intervention
Oral prophylactic interventionother
Likely dose
Not stated in record
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Search/NCT04989075
NCT04989075N/ACompleted

Effect of Oral Prophylactic Measures on the Occurrence of Pre-eclampsia (OP-PE) in High-risk Pregnant Women: A Cluster-randomized Controlled Trial

Claude Bernard University·interventional·Posted Aug 4, 2021·Updated Jul 30, 2025

In Brief

A clinical study evaluating Oral prophylactic intervention for Pregnancy Complications. Completed, enrolled 330 participants across 1 site.

Detailed Summary

Pre-eclampsia (PE) remains a major source of maternal and perinatal morbidity and mortality especially in low- and middle-income settings. PE, a pregnancy-specific hypertensive disorder, characterized by the development of placental endothelial dysfunction resulting in, among the most common diagnostic features, concomitant hypertension and proteinuria that may evolve into organs with fluctuating clinical specificities. Current studies indicate that 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, modulate of the dysbiotic oral microbiome. The purpose of the present study is to compare the PE outcomes in high-risk pregnant women receiving oral prophylactic measures to a control group. One specific question is addressed as follows according to the PICO principles: In high-risk pregnant women (Population), does oral prophylactic measures (Intervention) have a beneficial effect on PE parameters (Outcome) compared to pregnant women without any specific oral prophylactic measures (Control)?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSenegal

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 4, 2021
Enrollment StartMar 15, 2022
Primary CompletionApr 15, 2023
Study CompletionJul 25, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.9 years ago

Interventions

Oral prophylactic interventionother

The oral prophylactic intervention will consist of the provision of specific package including a soft-bristled manual toothbrush, toothpaste, and a kit of calibrated interdental brushes (IDBs)(Curaprox CPS; Curaden) of sizes corresponding to the diameter of their interdental spaces. The participants will be instructed to brush their teeeth twice-daily and to realise a daily interdental brushing until delivery. The instructions for the use of the toothbrush and IDBs comprised verbal instructions supported by practical demonstration. The first use of the material will be conducted under the supervision of a qualified public health professor.