Periodontal Disease and Small Vulnerable Newborns Trial, Nepal
ClinicalTrials.gov Studies
Summary
Phase 3 randomized controlled trial (n=2,280) registered on ClinicalTrials.gov examining whether improving periodontal health in pregnant women during the first trimester reduces the incidence of small vulnerable newborns (SVNs) in rural Sarlahi District, Nepal. The intervention includes daily antiseptic oral rinse (alcohol-free cetylpyridinium chloride 0.075%) and intensive oral hygiene education, with a biospecimen sub-study involving 200 participants. The trial targets primary outcomes of preterm birth, small-for-gestational age, and low birth weight.
“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.”
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What changed
This ClinicalTrials.gov registration documents a Phase 3 community-based randomized controlled trial investigating oral health interventions for pregnant women in rural Nepal. The trial will enroll 2,280 participants in Sarlahi District, providing an intervention package of daily antiseptic oral rinse (0.075% cetylpyridinium chloride) and intensive oral hygiene education from first trimester through delivery. A biospecimen sub-study will collect venous blood, gingival crevicular fluid, and plaque from 200 participants to explore relationships between subgingival inflammation, systemic inflammation, and SVN outcomes.
Affected parties include clinical investigators conducting maternal and neonatal health research, healthcare providers in South Asia working on preterm birth prevention, and public health authorities addressing neonatal mortality. The trial's findings may inform future clinical guidelines on periodontal care during pregnancy if the intervention demonstrates efficacy in reducing adverse birth outcomes.
Archived snapshot
Apr 28, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Phase 3 NCT07553286 Kind: PHASE3 Apr 27, 2026
Abstract
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...
Conditions: Preterm Birth, Low Birth Weight, Small Vulnerable Newborn, Small-for-gestational Age, Periodontal Disease
Interventions: A package of oral health interventions, including a daily antiseptic oral rinse (alcohol-free cetylpyridinium chloride (0.075%))
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