{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,25]],"date-time":"2026-04-25T15:19:40Z","timestamp":1777130380107,"version":"3.51.4"},"reference-count":23,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,10,15]],"date-time":"2024-10-15T00:00:00Z","timestamp":1728950400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,10,15]],"date-time":"2024-10-15T00:00:00Z","timestamp":1728950400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100001411","name":"Indian Council of Medical Research","doi-asserted-by":"publisher","award":["171811"],"award-info":[{"award-number":["171811"]}],"id":[{"id":"10.13039\/501100001411","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Trials"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Hypertensive disorders of pregnancy (HDP) pose significant risks to maternal and fetal health, with substantial mortality and morbidity rates globally, particularly in developing countries. Pre-eclampsia (PE) accounts for a notable portion of maternal morbidity and mortality, with varied prevalence across regions within countries like India. Despite advancements, disparities in healthcare access persist, influencing outcomes. PE not only affects maternal health during pregnancy but also predisposes women to long-term cardiovascular complications, emphasizing the need for early screening and preventive measures.\n<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This prospective randomized double-blind clinical trial aims to compare the efficacy and safety of 75\u00a0mg versus 150\u00a0mg aspirin for preventing preterm pre-eclampsia in high-risk women. Screen-positive women aged 18\u201345\u00a0years with singleton pregnancies between 12 and 16\u00a0weeks of gestational age will be enrolled. They will be randomized in a 1:1 ratio to receive either 75\u00a0mg or 150\u00a0mg of aspirin nightly until 37\u00a0weeks of pregnancy or earlier if preterm pre-eclampsia develops. Feto-maternal outcomes, including preterm pre-eclampsia incidence and neonatal and maternal complications, will be assessed. The sample size calculation based on expected proportions of preterm pre-eclampsia in both groups indicates a total of 370 participants (185 per group) accounting for 20% attrition.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>This prospective randomized double-blind clinical trial aims to compare the effectiveness and safety of two doses of aspirin (75\u00a0mg vs 150\u00a0mg) in preventing preterm pre-eclampsia in high-risk women. The potential implications of this study are significant, including the optimization of aspirin prophylaxis, the development of evidence-based guidelines, and comprehensive assessment of maternal and fetal outcomes. In conclusion, the results of this study have the potential to significantly impact clinical practice by enhancing maternal and perinatal health outcomes and contributing to evidence-based obstetric care.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>Clinical Trials Registry-India CTRI\/2023\/12\/060983. Trial was registered prospectively on 29 December 2023. Acknowledgement Number REF\/2023\/12\/076358. <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/acrobat.adobe.com\/id\/urn:aaid:sc:AP:15870322-f1f4-4460-900c-6e056ab83a44\">https:\/\/acrobat.adobe.com\/id\/urn:aaid:sc:AP:15870322-f1f4-4460-900c-6e056ab83a44<\/jats:ext-link>.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-024-08520-z","type":"journal-article","created":{"date-parts":[[2024,10,15]],"date-time":"2024-10-15T03:36:14Z","timestamp":1728963374000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Comparison of 75\u00a0mg versus 150\u00a0mg aspirin for the prevention of preterm preeclampsia in high-risk women at a tertiary level hospital: study protocol for a randomized double-blind clinical trial"],"prefix":"10.1186","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0472-9048","authenticated-orcid":false,"given":"Upma","family":"Saxena","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4339-2070","authenticated-orcid":false,"given":"Abhishek","family":"Lachyan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chanchal","family":"Goyal","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Garima","family":"Kapoor","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kavita","family":"Agarwal","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sidarrth","family":"Prasad","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2024,10,15]]},"reference":[{"issue":"3","key":"8520_CR1","doi-asserted-by":"publisher","first-page":"e0247782","DOI":"10.1371\/journal.pone.0247782.PMID:33690642;PMCID:PMC7943022","volume":"16","author":"R Van Doorn","year":"2021","unstructured":"Van Doorn R, Mukhtarova N, Flyke IP, Lasarev M, Kim K, Hennekens CH, et al. 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