Valentine Gregory C, Antony Kathleen M, Sangi-Haghpeykar Haleh, Wood Alexis C, Chirwa Rose, Petro Saukani, Dumba Mary, Nanthuru Deborah, Shope Cynthia, Mlotha-Namarika Jesse, Wilkinson Jeffrey, Aagaard Joshua, Aagaard Ellen J, Seferovic Maxim D, Levison Judy, Kazembe Peter, Aagaard Kjersti M
Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Baylor College of Medicine, 1 Baylor Plaza, Houston, TX 77030, USA; Baylor Foundation Malawi, Lilongwe, Malawi; Division of Neonatology, Department of Pediatrics, University of Washington, Seattle, WA 98195, USA.
Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Baylor College of Medicine, 1 Baylor Plaza, Houston, TX 77030, USA; Baylor Foundation Malawi, Lilongwe, Malawi; Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, University of Wisconsin-Madison, 202 South Park Street, Madison, WI 53715, USA.
Med. 2025 Apr 11;6(4):100539. doi: 10.1016/j.medj.2024.10.016. Epub 2024 Nov 13.
Maternal periodontal disease is associated with preterm and low-birthweight deliveries, but randomized trials of likely efficacious treatments (e.g., dental scaling and root planing) during pregnancy have not reduced these adverse outcomes. As an alternative, we hypothesized that periconception initiation of xylitol chewing gum would reduce the occurrence of preterm or low-birthweight deliveries among a historical high-prevalence population in Malawi.
We conducted an open-label, parallel-enrollment, matched-pair, cluster-randomized, controlled clinical trial across eight health centers (sites) in and around Lilongwe, Malawi. Sites were paired by anticipated delivery volume and randomized to prenatal and oral health education alone (active control) or with twice-daily xylitol chewing gum (intervention) throughout the periconception and antenatal periods. For the primary prevention of preterm (<37 weeks) and low-birthweight (<2,500 g) deliveries (co-primary outcomes), comparison by allocation group was performed using generalized linear mixed models for each outcome as a fixed factor and the site(s) as a random factor.
10,069 participants were enrolled (n = 4,549 at intervention sites, n = 5,520 at active control sites), with >95% available for analyses. Initiation of xylitol chewing gum resulted in significant reductions in the co-primary outcomes: preterm birth (12.6% [549/4,349] vs. 16.5% [878/5,321]; relative risk [RR] 0.76, 95% confidence interval [CI] 0.57-0.99) and <2,500-g neonates (8.9% [385/4,305] vs. 12.9% [679/5,260]; RR 0.70, 95% CI 0.49-0.99). Xylitol chewing gum use also led to fewer neonatal demises (0.2% [8/4,305] vs. 0.4% [22/5,260]; RR 0.41, 95% CI 0.19-0.89).
Periconception initiation and ongoing use of xylitol chewing gum significantly reduced the occurrence of preterm and low-birthweight deliveries in Malawi.
E.W. Al Thrasher Foundation (to K.A.) and USAID Saving Lives at Birth Grand Challenges Grant AID-OAA-G-11-00062 (to K.A.). Additional financial and in-kind support was graciously provided by Texas Children's Hospital and Baylor Foundation Malawi.
孕产妇牙周疾病与早产及低体重儿分娩有关，但孕期进行可能有效的治疗（如洗牙和龈下刮治）的随机试验并未减少这些不良结局。作为一种替代方法，我们推测在受孕前开始嚼木糖醇口香糖可减少马拉维一个历史高患病率人群中早产或低体重儿分娩的发生。
我们在马拉维利隆圭及其周边的八个健康中心（地点）开展了一项开放标签、平行入组、配对、整群随机对照临床试验。地点按预期分娩量配对，随机分为仅接受产前和口腔健康教育（积极对照）或在受孕前和孕期全程每日两次嚼木糖醇口香糖（干预）。对于早产（<37周）和低体重（<2500克）分娩的一级预防（共同主要结局），使用广义线性混合模型按分配组进行比较，每个结局作为固定因素，地点作为随机因素。
共纳入10069名参与者（干预组4549名，积极对照组5520名），超过95%可用于分析。开始嚼木糖醇口香糖使共同主要结局显著减少：早产（12.6%[549/4349]对16.5%[878/5321]；相对风险[RR]0.76，95%置信区间[CI]0.57 - 0.99）和<2500克新生儿（8.9%[385/4305]对12.9%[679/5260]；RR 0.70，95%CI 0.49 - 0.99）。嚼木糖醇口香糖还使新生儿死亡减少（0.2%[8/4305]对0.4%[22/5260]；RR 0.41，95%CI 0.19 - 0.89）。
受孕前开始并持续使用木糖醇口香糖可显著减少马拉维早产和低体重儿分娩的发生。
E.W.阿尔·思拉舍基金会（给K.A.）和美国国际开发署“出生时拯救生命大挑战”赠款AID - OAA - G - 1（给K.A.）。德克萨斯儿童医院和马拉维贝勒基金会慷慨提供了额外的资金和实物支持。
