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A description of the methods of the aspirin supplementation for pregnancy indicated risk reduction in nulliparas (ASPIRIN) study
- Source :
- BMC Pregnancy and Childbirth, Vol 17, Iss 1, Pp 1-15 (2017)
- Publication Year :
- 2017
- Publisher :
- BMC, 2017.
-
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
- Subjects :
- Prematurity
Preterm birth
Low dose Aspirin
Gynecology and obstetrics
RG1-991
Subjects
Details
- Language :
- English
- ISSN :
- 14712393
- Volume :
- 17
- Issue :
- 1
- Database :
- Directory of Open Access Journals
- Journal :
- BMC Pregnancy and Childbirth
- Publication Type :
- Academic Journal
- Accession number :
- edsdoj.b04749230cc347f89a09567a7270db3a
- Document Type :
- article
- Full Text :
- https://doi.org/10.1186/s12884-017-1312-x