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

Not Applicable

Completed

• Conditions: Pregnancy Complications

• Registration Number: NCT04989075
• Lead Sponsor: Claude Bernard University

Brief 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)?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-19
• Study First Submitted QC: 2021-07-24
• Study First Posted: 2021-08-04
• Study Start: 2022-03-15
• Primary Completion: 2023-04-15
• Study Completion: 2023-07-25
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-29
• Last Update Posted: 2025-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 330

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of pre-eclampsia from baseline during the pregnancy	9 months of 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: 1. 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,; 2. the proteinuria measured is of 2+ or more, or \> 300mg/24 hours, or \> 500mg/L or urinary protein/creatinine ratio \> 0.034g/mmol.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital; 🇸🇳 Dakar, Senegal