A description of the methods of the aspirin supplementation for pregnancy indicated risk reduction in nulliparas (ASPIRIN) study

Matthew Hoffman ,Archana Patel,Menachem Miodovnik,K Michael Hambidge,Dennis Wallace ,Antoinette Tshefu,Ana Garcés ,Patricia L Hibberd,Jennifer Hemingway-Foday ,Robert M Silver ,Elizabeth M Mcclure ,Fabian Esamai,Waldemar A Carlo,Carl Bose ,Bhalachandra S Kodkany,Robert L Goldenberg,Musaku Mwenechanya,Adrien Lokangaka,Marion Koso‐Thomas ,Elwyn Chomba,Edward A Liechty,Nancy F Krebs,Sarah Saleem,Norman Goco,Shivaprasad S Goudar,Richard J Derman

doi:10.1186/s12884-017-1312-x

Abstract

BackgroundPreterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the world. Though complex in its origins, a growing body of evidence suggests that first trimester administration of low dose aspirin (LDA) may substantially reduce the rate of PTB.MethodsHypothesis: LDA initiated in the first trimester reduces the risk of preterm birth.Study Design Type: Prospective randomized, placebo-controlled, double-blinded multi-national clinical trial conducted in seven low and middle income countries. Trial will be individually randomized with one-to-one ratio (intervention/control)Population: Nulliparous women between the ages of 14 and 40, with a singleton pregnancy between 6 0/7 weeks and 13 6/7 weeks gestational age (GA) confirmed by ultrasound prior to enrollment, no more than two previous first trimester pregnancy losses, and no contraindications to aspirin.Intervention: Daily administration of low dose (81 mg) aspirin, initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA, compared to an identical appearing placebo. Compliance and outcomes will be assessed biweekly.OutcomesPrimary outcome: Incidence of PTB (birth prior to 37 0/7 weeks GA).Secondary outcomes Incidence of preeclampsia/eclampsia, small for gestational age and perinatal mortality.DiscussionThis study is unique as it will examine the impact of LDA early in pregnancy in low-middle income countries with preterm birth as a primary outcome. The importance of developing low-cost, high impact interventions in low-middle income countries is magnified as they are often unable to bear the financial costs of treating illness.Trial registrationClinicalTrials.gov identifier: NCT02409680 Date: March 30, 2015

Highlights

Preterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the world
It would be of interest to study the effect of low dose aspirin (LDA) in women at high risk for preterm birth, such women may undergo interventions intended to decrease their risk of preterm birth
Available data suggest that LDA may be a safe, widely available and inexpensive intervention that may significantly reduce the risk of preterm birth

Summary

Introduction

Preterm birth (PTB) remains the leading cause of neonatal mortality and long term disability throughout the world. Though complex in its origins, a growing body of evidence suggests that first trimester administration of low dose aspirin (LDA) may substantially reduce the rate of PTB. Infants born prematurely are at increased risk for long term medical complications such as respiratory, gastrointestinal, cardiovascular, metabolic, and neurodevelopmental disorders [6, 7]. Financial and emotional burden of preterm birth in the developing world and the limited resources to provide neonatal care, any interventions with the potential to reduce the rate of preterm birth deserve consideration. Low dose aspirin (LDA) may be just such an intervention.[6, 7]

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