NCT04989075: OP-PE

Oral Prophylactic Measures on the Occurrence of Pre-eclampsia (OP-PE)

Completed NA Last updated 30 July 2025

What this trial tests

NA trial testing Oral prophylactic intervention in Pregnancy Complications in 330 participants. Completed in 25 July 2023.

Timeline

15 March 2022

Primary endpoint
15 April 2023

25 July 2023

Quick facts

Lead sponsor	Claude Bernard University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	330
Start date	15 March 2022
Primary completion	15 April 2023
Estimated completion	25 July 2023
Sites	1 location across Senegal

Drugs / interventions tested

• Oral prophylactic intervention

Conditions studied

• Pregnancy Complications — all drugs for Pregnancy Complications →

Sponsor

Claude Bernard University

Who can join

Adults 18 to 40, female only, with Pregnancy Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)?

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prevalence, Severity of Extension, and Risk Factors of Gingivitis in a 3-Month Pregnant Population: A Multicenter Cross-Sectional Study.
   Gare J, Kanoute A, Orsini G, Gonçalves LS, et al · · 2023 · cited 13× · PMID 37176789 · DOI 10.3390/jcm12093349
2. Periodontal pathogens of the interdental microbiota in a 3 months pregnant population with an intact periodontium.
   Carrouel F, Kanoute A, Lvovschi VE, Bourgeois D. · · 2023 · cited 7× · PMID 38029104 · DOI 10.3389/fmicb.2023.1275180
3. Effect of Oral Prophylactic Measures on the Occurrence of Pre-Eclampsia (OP-PE) in High-Risk Pregnant Women: A Cluster Randomized Controlled Trial.
   Kanoute A, Gare J, Meda N, Viennot S, et al · · 2021 · cited 4× · PMID 34564307 · DOI 10.3390/mps4030061
4. Interdental Brushing and Obstetrical Outcomes in Nulliparous Pregnant Women: Insights From a Cluster Randomised Controlled Trial.
   Bourgeois D, Kanoute A, Faye D, Mazur M, et al · · 2026 · cited 3× · PMID 41367200 · DOI 10.1111/jcpe.70070
5. Oral prophylaxis for the reduction of interdental dysbiosis-associated red complex pathogens during pregnancy: a randomized clinical trial.
   Carrouel F, Kanoute A, Faye D, Rhanoui M, et al · · 2026 · PMID 42110445 · DOI 10.3389/fmed.2026.1798508
6. Impact of Interdental Brushing on Pregnancy-Associated Gingivitis: A Secondary Analysis of a Randomised Controlled Trial.
   Carrouel F, Kanoute A, Faye D, Mazur M, et al · · 2026 · PMID 41558746 · DOI 10.1111/jcpe.70085