Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 2,280
- 主要终点
- Proportion of small vulnerable newborn births
研究概览
简要总结
Periodontal disease in pregnant women has been implicated as a potential risk factor for adverse pregnancy outcomes, including being born preterm, small-for-gestational age, and/or low birth weight. Infants who have at least one of these outcomes, known as small vulnerable newborns (SVN)), are at increased risk of early death and poor infant growth and development. Rigorous, high-quality randomized trials are needed to evaluate whether improving the periodontal health of pregnant women can reduce the risk of adverse pregnancy outcomes in areas like South Asia, where these outcomes are common and neonatal mortality remains high. This study is a community-based, randomized controlled trial (n=2,280) to evaluate a package of oral health interventions delivered to pregnant women in the first trimester until delivery on the incidence of SVNs in rural Sarlahi District, Nepal. The intervention package will include a daily antiseptic oral rinse and intensive oral hygiene education and instruction. Both intervention and control groups will be provided a manual toothbrush and toothpaste. The investigators will determine intervention effects on incidence of SVNs and individual outcomes of preterm birth, small-for-gestational age, and low birth weight. In a biospecimen sub-study (n=200), the investigators will collect venous blood, gingival crevicular fluid, and plaque in early and late pregnancy to explore relationships between subgingival inflammation, systemic inflammation, and SVN types and other adverse pregnancy outcomes. If efficacious, a low-cost package of oral health interventions - including an antiseptic oral rinse, intensive oral hygiene education and instruction, and provision of a manual toothbrush and toothpaste - could improve maternal and newborn outcomes at this critical time of growth and development.
详细描述
Study Aims:
The primary aim of the study is to determine the effect of a package of oral health interventions in pregnancy on the incidence of small vulnerable newborns (SVN).
- Hypothesis 1a: The oral health intervention will reduce overall incidence of SVNs at birth and individual outcomes of preterm birth, small-for-gestational age (SGA), and low birth weight (LBW).
- Hypothesis 1b: The intervention will have a larger effect on high-risk groups, including women who are younger/older, undernourished (low body mass index, low dietary diversity), or have more severe periodontal disease at enrollment.
- Hypothesis 1c: Adherence to the intervention will modify the effect of the intervention on the primary and secondary outcomes in a dose-response relationship.
Aim 2 will explore relationships between subgingival inflammation, systemic inflammation, and incidence of SVNs.
- Hypothesis 2a: The oral health intervention will reduce levels of subgingival inflammatory mediators between early and late pregnancy in the intervention group (IL-1β, IL-6, IL-8, TNF-α, etc.) relative to changes in the control group.
- Hypothesis 2b: Lower levels of subgingival inflammatory mediators will be associated with reduced risk for SVNs, shorter gestation, and low infant weight-for-age and weight at birth.
- Hypothesis 2c: Systemic inflammatory mediators will mediate the effect of subgingival inflammation levels on SVNs and adverse pregnancy outcomes.
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
- None
盲法说明
The investigators will try to mask outcome assessors to participant's allocation to the extent possible.
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Married women of reproductive age (15-35 years).
- •Living in the study area who are pregnant and consent to participate.
排除标准
- •Currently pregnant women.
- •Women who are sterilized or use long-acting contraceptive methods or are divorced or widowed.
- •Women identified as pregnant ≥12 gestational weeks based upon date of last menstrual period.
研究组 & 干预措施
Control arm
Pregnant women randomized to the control group will receive basic oral health information and a manual toothbrush and toothpaste. Basic oral health information will consist of a short brief at enrollment about oral hygiene, including brushing twice daily, not smoking, avoiding sugary foods and beverages, and the importance of preventive dental care. The investigators do not anticipate this will impact the exposure or outcome.
Package of oral health interventions
Pregnant women randomized to the intervention group will receive a home-based package, including antiseptic oral rinse (alcohol-free cetylpyridinium chloride (CPC) (0.075%)), intensive oral hygiene instruction, and a manual toothbrush and toothpaste.
干预措施: A package of oral health interventions, including a daily antiseptic oral rinse (alcohol-free cetylpyridinium chloride (0.075%)) (Drug)
结局指标
主要结局
Proportion of small vulnerable newborn births
时间窗: At the time of delivery.
The primary trial outcome is the proportion of live births classified as small vulnerable newborn (SVN), defined as a composite of preterm birth (PT; \<37 weeks' gestation), small-for-gestational age (SGA; birth weight \<10% for gestational age and sex using the INTERGROWTH-21st reference standard), and/or low birth weight (LBW; \<2,500g). A live-born infant meeting at least one of these criteria will be classified as an SVN birth.
次要结局
- Proportion of small vulnerable newborn types(At the time of delivery.)
- Proportion of preterm births(At the time of delivery.)
- Proportion of small-for-gestational age (SGA) births(At the time of delivery.)
- Proportion of low birth weight births(At the time of delivery.)