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

Academic Article

Abstract

  • BACKGROUND: 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. METHODS: Hypothesis: 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. OUTCOMES: Primary 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. DISCUSSION: This 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 REGISTRATION: ClinicalTrials.gov identifier: NCT02409680 Date: March 30, 2015.
  • Authors

    Published In

    Keywords

  • Low dose Aspirin, Prematurity, Preterm birth, Adolescent, Adult, Anti-Inflammatory Agents, Non-Steroidal, Aspirin, Developing Countries, Double-Blind Method, Female, Gestational Age, Humans, Incidence, Infant, Infant Mortality, Infant, Small for Gestational Age, Parity, Pre-Eclampsia, Pregnancy, Pregnancy Trimester, First, Premature Birth, Prospective Studies, Treatment Outcome, Young Adult
  • Digital Object Identifier (doi)

    Author List

  • Hoffman MK; Goudar SS; Kodkany BS; Goco N; Koso-Thomas M; Miodovnik M; McClure EM; Wallace DD; Hemingway-Foday JJ; Tshefu A
  • Start Page

  • 135
  • Volume

  • 17
  • Issue

  • 1