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

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.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.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

Low-dose aspirin for the prevention of preterm delivery in nulliparous women with a singleton pregnancy (ASPIRIN): a randomised, double-blind, placebo-controlled trial

“…The trial was conducted by the NICHD Global Network for Women's and Children's Health Research in 7 sites in 6 countries-India (2 sites), Pakistan, Zambia, Democratic Republic of Congo, Guatemala and Kenya -between March 2016 and April 2019. The trial protocol (available with the full text of this article at NEJM.org) has been previously published 15 . Prior to the initiation of the trial, the protocol was approved by the relevant ethics committees and regulatory agencies of each country as well as the ethics committees of the United States-based collaborators and that of the Research Triangle Institute (RTI) International.…”

The predictive capacity of uterine artery Doppler for preterm birth—A cohort study

“…Our results, with a higher risk of late spontaneous PTB in women with an abnormal UtA Doppler, strengthen the hypothesis that impaired placental function has a relation with spontaneous PTB. Current research focuses on antiplatelet therapy as a new strategy in the prevention of PTB . Recent studies report a reduction in spontaneous PTB before 34 weeks if antiplatelet therapy is started between 13 and 25 weeks of gestation .…”

“…Current research focuses on antiplatelet therapy as a new strategy in the prevention of PTB. [25][26][27][28] Recent studies report a reduction in spontaneous PTB before 34 weeks if antiplatelet therapy is started between 13 and 25 weeks of gestation. 29 We suggest increased surveillance in women with an abnormal UtA Doppler in the second trimester.…”

Low molecular weight heparin and aspirin exacerbate human endometrial endothelial cell responses to antiphospholipid antibodies

“…LMWH is commonly used as an anticoagulant treatment in systemic APS, and early initiation of aspirin (prior to 16 weeks of gestation) is thought to be beneficial for fetal development . Both therapies are given empirically to women with recurrent miscarriage, whether it is due to APS or not .…”