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

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

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 Overview

• Status: Completed
• Conditions: Pregnancy Complications
• Intervention / Treatment: Other: Oral prophylactic intervention

• Study Type: Interventional
• Enrollment (Actual): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Senegal
  • Dakar, Senegal
    • Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• pregnant woman
• women from sub-Saharan Africa
• aged from 18 to 40 years old
• nullipares at the time of the obstetrical consultation
• up to 12 weeks pregnant
• acceptance of the terms and conditions of the study
• signature of the informed consent form,

Exclusion Criteria:

• fetal distress
• congenital uterine and vaginal abnormalities
• infectious or systemic diseases such as HIV, tuberculosis, candidiasis, cancers, hemopathies
• premature termination of pregnancy for medical reasons
• diagnosis of periodontitis defined as interproximal CAL ≥1 mm at ≥2 non-adjacent teeth, or buccal/oral CAL ≥3 mm with probing depth >3 mm at ≥2 teeth, not attributable to non-periodontitis-related causes
• history or treatment of PD
• a course of dental or orthodontic treatment
• absence of the 4 premolar-molar pairs
• less than 20 natural teeth, excluding third molars
• medication affecting the gum and/or oral mucosa
• regularly using interdental brushes and/or dental floss and/or mouthwash
• unable to answer questions or non-cooperative.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; The control group will continue its usual oral hygiene practice.
Experimental: Oral prophylactic intervention; For the study group, the oral prophylactic intervention will consist of provision of specfic package including 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.	Other: Oral prophylactic intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pre-eclampsia from baseline during the pregnancy	To determine if pregnant women suffer from pre-eclampsia, several indices are measured (diastolic or systolic pressure and proteinuria or urinary protein/creatinine ratio). The combination of the results of pressure and proteinuria permits to classify of a woman as suffering from pre-eclampsia if: the diastolic pressure is higher than 90 mm Hg on two 4 hours intervals, or > 110 mm Hg once, or systolic pressure > 140 mm Hg on two 4 hours intervals, or > 160 mm Hg once, after 20 weeks of gestation and,; the proteinuria measured is of 2+ or more, or > 300mg/24 hours, or > 500mg/L or urinary protein/creatinine ratio > 0.034g/mmol.	9 months of pregnancy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of pathogenic bacteria in the interdental microbiota during the pregnancy	Quantitative PCR experiments will be performed and a quantitative analysis of the interdental microbiota will be made	3, 4, 6 and 8 months of pregnancy
Change of bleeding on probing during the pregnancy	Quantification of the bleeding on probing of the teeth with a periodontal probe	3, 4, 6 and 8 months of pregnancy
Change of pocket probing depth of teeth during the pregnancy	Quantification of the pocket probing depth of the teeth with a periodontal probe	3, 4, 6 and 8 months of pregnancy
Change of clinical attachment level of teeth during the pregnancy	Quantification of the clinical attachment level of the teeth with a periodontal probe	3, 4, 6 and 8 months of pregnancy
Change of gingival index of teeth during the pregnancy	Quantification of the gingival index	3, 4, 6 and 8 months of pregnancy

Collaborators and Investigators

• Sponsor: Claude Bernard University
• Collaborators: Cheikh Anta Diop University, Senegal; University of Ouagadougou, Burkina Faso
• Investigators: Study Director: Florence Carrouel, Dr, P2S, UR4129, University of Lyon

Publications and helpful links

General Publications

• Gare J, Kanoute A, Meda N, Viennot S, Bourgeois D, Carrouel F. Periodontal Conditions and Pathogens Associated with Pre-Eclampsia: A Scoping Review. Int J Environ Res Public Health. 2021 Jul 5;18(13):7194. doi: 10.3390/ijerph18137194.

Helpful Links

• Article

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): July 25, 2023

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: July 24, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 29, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: pregnant; periodontal disease; pre-eclampsia; interdental microbiota
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia; Pregnancy Complications
• Other Study ID Numbers: OP-PE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No