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.
Married women of reproductive age (15-35 years).
Living in the study area who are pregnant and consent to participate.
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.
Parallel
A package of oral health interventions, including a daily antiseptic oral rinse (alcohol-free cetylpyridinium chloride (0.075%))
DrugThe oral health intervention package will be home-based and will include a daily antiseptic oral rinse (alcohol-free cetylpyridinium chloride (CPC) (0.075%)), intensive oral hygiene instruction, and a manual toothbrush and toothpaste. Participants will rinse twice daily with 10 ml after brushing teeth for 1 minute. A one-on-one oral hygiene education session will be delivered at the participant's home lasting about one hour. Instruction will cover the basics of periodontal disease and dental caries, risk factors for these conditions, and proper oral hygiene behaviors, including use of toothbrushing and toothpaste, interdental cleaning, and antiseptic mouthwash. The session will include a demonstration by the data collector and time for the participant to practice the behaviors. An instructional pictorial guide in Nepali or Maithili, depending upon the participant's language, will be left with the participant.
Proportion of small vulnerable newborn births
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.
Proportion of small vulnerable newborn types
Live births will be categorized into four mutually exclusive groups: term and appropriate-for-gestational age (T+AGA; reference), term and small-for-gestational age (T+SGA), preterm and appropriate-for-gestational age (PT+AGA), and preterm and small-for-gestational age (PT+SGA). AGA will be defined as birth weight \>10% for gestational age and sex, and SGA as birth weight \<10%, according to the INTERGROWTH-21st reference standard.
Proportion of preterm births
The proportion of live births classified as preterm, defined as gestational age at the time of delivery \<37 weeks (up to 36 weeks + 6 days).
Proportion of small-for-gestational age (SGA) births
The proportion of live births classified as SGA, defined as birth weight \<10% for gestational age and sex using the INTERGROWTH-21st reference standard.
Proportion of low birth weight births
The proportion of live births classified as LBW, defined as birth weight \<2,500 g.
Change from Early to Late Pregnancy in the Proportion of Participants With Periodontal Disease
Change from early to late pregnancy in the proportion of participants with periodontal disease. Periodontal disease will be defined as bleeding on probing (BOP) ≥10% and/or ≥1 site with probing pocket depth (PPD) ≥5mm. Gingivitis will be defined as localized (BOP 10%-\<30%) or generalized gingivitis (BOP ≥ 30%) with no sites PPD ≥5 mm. Periodontitis will be defined as ≥1 site with PPD ≥5 mm.
Change From Early to Late Pregnancy in Mean Gingival Crevicular Fluid Inflammatory Mediator Levels
Change from early to late pregnancy in mean gingival crevicular fluid inflammatory mediator levels. Inflammatory mediators may include IL-1β, IL-4, IL-6, IL-8, IL-10, IL-17, IL-12p70, tumor necrosis factor- α (TNF-α), macrophage inflammatory protein-1α (MIP-1α), and C-reactive protein (CRP).
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Johns Hopkins Bloomberg School of Public Health
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
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