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

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Creator
  • Patel, Archana
    • Other Affiliation: Lata Medical Research Foundation, Nagpur, India
  • Garces, Ana
    • Other Affiliation: Instituto de Nutrición de Centroamérica y Panamá (INCAP), Guatemala City, Guatemala
  • Esamai, Fabian
    • Other Affiliation: Department of Child Health and Paediatrics, Moi University School of Medicine, Eldoret, Kenya
  • Miodovnik, Menachem
    • Other Affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA
  • Koso-Thomas, Marion
    • Other Affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA
  • Krebs, Nancy F.
    • Other Affiliation: University of Colorado School of Medicine, Denver, CO, USA
  • Goldenberg, Robert L.
    • Other Affiliation: Columbia University, New York, NY, USA
  • Bose, Carl
    • Affiliation: School of Medicine, Department of Pediatrics
  • Tshefu, Antoinette
    • Other Affiliation: Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo
  • Mwenechanya, Musaku
    • Other Affiliation: University Teaching Hospital, Lusaka, Zambia
  • Hoffman, Matthew K.
    • Other Affiliation: Christiana Care, Newark, DE, USA
  • Derman, Richard J.
    • Other Affiliation: Thomas Jefferson University, Philadelphia, PA, USA
  • Kodkany, Bhalachandra S.
    • Other Affiliation: KLE’s JN Medical College, Belgaum, India
  • Lokangaka, Adrien
    • Other Affiliation: Kinshasa School of Public Health, Kinshasa, Democratic Republic of the Congo
  • Wallace, Dennis D.
    • Other Affiliation: RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, USA
  • Hemingway-Foday, Jennifer J.
    • Other Affiliation: RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, USA
  • Carlo, Waldemar A.
    • Other Affiliation: University of Alabama at Birmingham, Birmingham, AL, USA
  • Saleem, Sarah
    • Other Affiliation: Aga Khan University, Karachi, Pakistan
  • Liechty, Edward A.
    • Other Affiliation: School of Medicine, Indiana University, Indianapolis, IN, USA
  • Hambidge, K. M.
    • Other Affiliation: University of Colorado School of Medicine, Denver, CO, USA
  • Chomba, Elwyn
    • Other Affiliation: University Teaching Hospital, Lusaka, Zambia
  • Hibberd, Patricia L.
    • Other Affiliation: Boston University School of Public Health, Boston, MA, USA
  • McClure, Elizabeth M.
    • Other Affiliation: RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, USA
  • Silver, Robert
    • Other Affiliation: University of Utah, Salt Lake City, UT, USA
  • Goco, Norman
    • Other Affiliation: RTI International, 3040 E. Cornwallis Road, Research Triangle Park, NC, USA
  • Goudar, Shivaprasad S.
    • Other Affiliation: KLE’s JN Medical College, Belgaum, India
Abstract
  • 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
Date of publication
Identifier
  • doi:10.1186/s12884-017-1312-x
Resource type
  • Article
Rights statement
  • In Copyright
Rights holder
  • The Author(s).
Language
  • English
Bibliographic citation
  • BMC Pregnancy and Childbirth. 2017 May 03;17(1):135
Publisher
  • BioMed Central
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