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

Study Overview
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Brief Summary
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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)?

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

Conditions
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Pregnancy Complications

Intervention / Treatment
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* Other: Oral prophylactic intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pregnant woman women from sub-Saharan Africa aged from 18 to 35 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 periodontal lesions of stage II, III (i.e., PD ≥ 4 mm, and/or CAL ≥ 4 mm), generalized (>30% of sites) history or treatment of PD a course of dental or orthodontic treatment 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This trial is designed as an two-arm parallel cluster randomized controlled trial with antenatal obstetric clinic as the unit of randomisation and an allocation ratio of 1:1
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>The control group will continue its usual oral hygiene practice. | |
| Experimental: Oral prophylactic intervention<br>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<br>* 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.<br>|

What is the study measuring?
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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 months, 6 months 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, 5, 6, 7, 8 and 9 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, 5, 6, 7, 8 and 9 months of pregnancy | 
| Change of gingival index of teeth during the pregnancy | Quantification of the gingival index | 3, 4, 5, 6, 7, 8 and 9 months of pregnancy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre-eclampsia, pregnant, periodontal disease, interdental microbiota