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. Hibberd; Emmah 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

doi:10.1016/j.xagr.2021.100003

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

Department of Community Health Sciences, Medical College, Pakistan

Research output: Contribution to journal › Article › peer-review

8 Citations (Scopus)

Abstract

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 language	English
Article number	100003
Journal	AJOG Global Reports
Volume	1
Issue number	1
DOIs	https://doi.org/10.1016/j.xagr.2021.100003
Publication status	Published - Feb 2021

Keywords

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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.xagr.2021.100003

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Short, V. L., Hoffman, M., Metgud, M., Kavi, A., Goudar, S. S., Okitawutshu, J., Tshefu, A., Bose, C. L., Mwenechanya, M., Chomba, E., Carlo, W. A., Figueroa, L., Garces, A., Krebs, N. F., Jessani, S., Saleem, S., Goldenberg, R. L., Das, P. K., Patel, A., ... Derman, R. J. (2021). Safety of daily low-dose aspirin use during pregnancy in low-income and middle-income countries. AJOG Global Reports, 1(1), Article 100003. https://doi.org/10.1016/j.xagr.2021.100003

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title = "Safety of daily low-dose aspirin use during pregnancy in low-income and middle-income countries",

abstract = "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{\textquoteright} 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{\textquoteright} gestation in low- and middle-income countries.",

keywords = "low- and middle-income countries, low-dose aspirin, potential side effects, pregnancy, preterm birth, safety, unexpected emergency medical visits",

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

note = "Publisher Copyright: {\textcopyright} 2021 The Authors",

year = "2021",

month = feb,

doi = "10.1016/j.xagr.2021.100003",

language = "English",

volume = "1",

journal = "AJOG Global Reports",

issn = "2666-5778",

publisher = "Elsevier Inc.",

number = "1",

}

Short, VL, Hoffman, M, Metgud, M, Kavi, A, Goudar, SS, Okitawutshu, J, Tshefu, A, Bose, CL, Mwenechanya, M, Chomba, E, Carlo, WA, Figueroa, L, Garces, A, Krebs, NF, Jessani, S , Saleem, S, Goldenberg, RL, Das, PK, Patel, A, Hibberd, PL, Achieng, E, Nyongesa, P, Esamai, F, Bucher, S, Nowak, KJ, Goco, N, Nolen, TL, McClure, EM, Koso-Thomas, M, Miodovnik, M & Derman, RJ 2021, 'Safety of daily low-dose aspirin use during pregnancy in low-income and middle-income countries', AJOG Global Reports, vol. 1, no. 1, 100003. https://doi.org/10.1016/j.xagr.2021.100003

TY - JOUR

T1 - Safety of daily low-dose aspirin use during pregnancy in low-income and middle-income countries

AU - Short, Vanessa L.

AU - Hoffman, Matthew

AU - Metgud, Mrityunjay

AU - Kavi, Avinash

AU - Goudar, Shivaprasad S.

AU - Okitawutshu, Jean

AU - Tshefu, Antoinette

AU - Bose, Carl L.

AU - Mwenechanya, Musaku

AU - Chomba, Elwyn

AU - Carlo, Waldemar A.

AU - Figueroa, Lester

AU - Garces, Ana

AU - Krebs, Nancy F.

AU - Jessani, Saleem

AU - Saleem, Sarah

AU - Goldenberg, Robert L.

AU - Das, Prabir Kumar

AU - Patel, Archana

AU - Hibberd, Patricia L.

AU - Achieng, Emmah

AU - Nyongesa, Paul

AU - Esamai, Fabian

AU - Bucher, Sherri

AU - Nowak, Kayla J.

AU - Goco, Norman

AU - Nolen, Tracy L.

AU - McClure, Elizabeth M.

AU - Koso-Thomas, Marion

AU - Miodovnik, Menachem

AU - Derman, Richard J.

PY - 2021/2

Y1 - 2021/2

N2 - 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.

AB - 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.

KW - low- and middle-income countries

KW - low-dose aspirin

KW - potential side effects

KW - pregnancy

KW - preterm birth

KW - safety

KW - unexpected emergency medical visits

UR - http://www.scopus.com/inward/record.url?scp=85127547227&partnerID=8YFLogxK

U2 - 10.1016/j.xagr.2021.100003

DO - 10.1016/j.xagr.2021.100003

M3 - Article

AN - SCOPUS:85127547227

SN - 2666-5778

VL - 1

JO - AJOG Global Reports

JF - AJOG Global Reports

IS - 1

M1 - 100003

ER -

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

Abstract

Keywords

UN SDGs

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