TY - JOUR
T1 - A description of the methods of the aspirin supplementation for pregnancy indicated risk reduction in nulliparas (ASPIRIN) study
AU - Hoffman, Matthew K.
AU - Goudar, Shivaprasad S.
AU - Kodkany, Bhalachandra S.
AU - Goco, Norman
AU - Koso-Thomas, Marion
AU - Miodovnik, Menachem
AU - McClure, Elizabeth M.
AU - Wallace, Dennis D.
AU - Hemingway-Foday, Jennifer J.
AU - Tshefu, Antoinette
AU - Lokangaka, Adrien
AU - Bose, Carl L.
AU - Chomba, Elwyn
AU - Mwenechanya, Musaku
AU - Carlo, Waldemar A.
AU - Garces, Ana
AU - Krebs, Nancy F.
AU - Hambidge, K. Michael
AU - Saleem, Sarah
AU - Goldenberg, Robert L.
AU - Patel, Archana
AU - Hibberd, Patricia L.
AU - Esamai, Fabian
AU - Liechty, Edward A.
AU - Silver, Robert
AU - Derman, Richard J.
N1 - Publisher Copyright:
© 2017 The Author(s).
PY - 2017/5/3
Y1 - 2017/5/3
N2 - 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
AB - 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
KW - Low dose Aspirin
KW - Prematurity
KW - Preterm birth
UR - http://www.scopus.com/inward/record.url?scp=85018751384&partnerID=8YFLogxK
U2 - 10.1186/s12884-017-1312-x
DO - 10.1186/s12884-017-1312-x
M3 - Article
C2 - 28468653
AN - SCOPUS:85018751384
SN - 1471-2393
VL - 17
JO - BMC Pregnancy and Childbirth
JF - BMC Pregnancy and Childbirth
IS - 1
M1 - 135
ER -