2017 Articles

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

Hoffman, Matthew K.; Goudar, Shivaprasad S.; Kodkany, Bhalachandra S.; Goco, Norman; Koso-Thomas, Marion; Miodovnik, Menachem; McClure, Elizabeth M.; Wallace, Dennis D.; Hemingway-Foday, Jennifer J.; Tshefu, Antoinette; Lokangaka, Adrien; Bose, Carl L.; Chomba, Elwyn; Mwenechanya, Musaku; Carlo, Waldemar A.; Garces, Ana; Krebs, Nancy F.; Hambidge, K. M.; Saleem, Sarah; Goldenberg, Robert L.; Patel, Archana; Hibberd, Patricia L.; Esamai, Fabian; Liechty, Edward A.; Silver, Robert; Derman, Richard J.

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