A description of the methods of the aspirin supplementation for pregnancy indicated risk reduction in nulliparas (ASPIRIN) study
Year: 2017
Type: article
Study design: Study Protocol
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.
Source: BMC Pregnancy and Childbirth
Authors: Matthew K. Hoffman, Shivaprasad S. Goudar, Bhalachandra S. Kodkany, Norman Goco, Marion Koso-Thomas, Menachem Miodovnik, Elizabeth M. McClure, Dennis D. Wallace, Jennifer J. Hemingway-Foday, Antoinette Tshefu, Adrien Lokangaka, Carl L. Bose, Elwyn Chomba, Musaku Mwenechanya, Waldemar A. Carlo, Ana Garces, Nancy F. Krebs, K. Michael Hambidge, Sarah Saleem, Robert L. Goldenberg, Archana Patel, Patricia L. Hibberd, Fabian Esamai, Edward A. Liechty, Robert Silver, Richard J. Derman
Institutions: Christiana Hospital, RTI International, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Ecole de santé publique de Kinshasa, University of North Carolina at Chapel Hill, University Teaching Hospital, University of Alabama at Birmingham, Institute of Nutrition of Central America and Panama, University of Colorado Anschutz, University of Colorado Denver, Aga Khan University, Columbia University, Lata Medical Research Foundation, Boston University, Moi University, Indiana University Indianapolis, Indiana University School of Medicine, University of Utah, Thomas Jefferson University
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,290
Awards: G1472282359, The Global Network and Preconception Maternal Nutrition, Global Network for Women's & Children's Health Research Data Coordinating Center, G2063538778, G4161767132, Columbia University/Aga Khan University Global Network Research Unit, G472522141, Maternal and Child Health Benefits from Reducing Household Air Pollution, G5426933423, A Strategy to Reduce Stunting of Growth in Early Infancy: a Global Network Study, CCHS-JNMC Global Network for Women's & Children's Health Research Unit
OpenAlex ID: W2611282986