Effect of Oral Prophylactic Measures on the Occurrence of Pre-eclampsia (OP-PE) in High-risk Pregnant Women: A Cluster-randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Incidence of pre-eclampsia from baseline during the pregnancy
研究概览
简要总结
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)?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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,
排除标准
- •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.
结局指标
主要结局
Incidence of pre-eclampsia from baseline during the pregnancy
时间窗: 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.
次要结局
- Change of bleeding on probing during the pregnancy(3, 4, 6 and 8 months of pregnancy)
- Number of pathogenic bacteria in the interdental microbiota during the pregnancy(3, 4, 6 and 8 months of pregnancy)
- Change of pocket probing depth of teeth during the pregnancy(3, 4, 6 and 8 months of pregnancy)
- Change of clinical attachment level of teeth during the pregnancy(3, 4, 6 and 8 months of pregnancy)
- Change of gingival index of teeth during the pregnancy(3, 4, 6 and 8 months of pregnancy)
研究者
Carrouel Florence
Associate professor
Claude Bernard University