Safety of daily low-dose aspirin use during pregnancy in low-income and middle-income countries

Vanessa L. Short, Matthew Hoffman, Mrityunjay Metgud, Avinash Kavi, Shivaprasad S. Goudar, Jean Okitawutshu, Antoinette Tshefu, Carl L. Bose, Musaku Mwenechanya, Elwyn Chomba, Waldemar A. Carlo, Lester Figueroa, Ana Garces, Nancy F. Krebs, Saleem Jessani, Sarah Saleem, Robert L. Goldenberg, Prabir Kumar Das, Archana Patel, Patricia L. HibberdEmmah Achieng, Paul Nyongesa, Fabian Esamai, Sherri Bucher, Kayla J. Nowak, Norman Goco, Tracy L. Nolen, Elizabeth M. McClure, Marion Koso-Thomas, Menachem Miodovnik, Richard J. Derman

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8 Citations (Scopus)


BACKGROUND: The daily use of low-dose aspirin may be a safe, widely available, and inexpensive intervention for reducing the risk of preterm birth. Data on the potential side effects of low-dose aspirin use during pregnancy in low- and middle-income countries are needed. OBJECTIVE: This study aimed to assess differences in unexpected emergency medical visits and potential maternal side effects from a randomized, double-blind, multicountry, placebo-controlled trial of low-dose aspirin use (81 mg daily, from 6 to 36 weeks’ gestation). STUDY DESIGN: This study was a secondary analysis of data from the Aspirin Supplementation for Pregnancy Indicated Risk Reduction In Nulliparas trial, a trial of the Global Network for Women's and Children's Health conducted in India (2 sites), Pakistan, Guatemala, Democratic Republic of the Congo, Kenya, and Zambia. The outcomes for this analysis were unexpected emergency medical visits and the occurrence of the following potential side effects—overall and separately—nausea, vomiting, rash or hives, diarrhea, gastritis, vaginal bleeding, allergic reaction, and any other potential side effects. Analyses were performed overall and by geographic region. RESULTS: Between the aspirin (n=5943) and placebo (n=5936) study groups, there was no statistically significant difference in the risk of unexpected emergency medical visits or the risk of any potential side effect (overall). Of the 8 potential side effects assessed, only 1 (rash or hives) presented a different risk by treatment group (4.2% in the aspirin group vs 3.5% in the placebo group; relative risk, 1.20; 95% confidence interval, 1.01–1.43; P=.042). CONCLUSION: The daily use of low-dose aspirin seems to be a safe intervention for reducing the risk of preterm birth and well tolerated by nulliparous pregnant women between 6 and 36 weeks’ gestation in low- and middle-income countries.

Original languageEnglish
Article number100003
JournalAJOG Global Reports
Issue number1
Publication statusPublished - Feb 2021


  • low- and middle-income countries
  • low-dose aspirin
  • potential side effects
  • pregnancy
  • preterm birth
  • safety
  • unexpected emergency medical visits


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