Does Adherence Modify Low-Dose Aspirin Effects in Pregnancy? Post Hoc Analysis From a Multi-Centre Trial.
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Mwenechanya Musaku, Tembo Abigail Mwapule, Chomba Elwyn, Hoffman Matthew K, Goudar Shivaprasad S, Moore Janet L, Metgud Mrityunjay C, Somannavar Manjunath S, Okitawutshu Jean, Lokangaka Adrien L, Tshefu Antoinette K, Bose Carl L, Bauserman Melissa S, Figueroa Lester, Garces Ana, Krebs Nancy F, Jessani Saleem, Saleem Sarah, Goldenberg Robert L, Kurhe Kunal, Das Prabir, Patel Archana B, Hibberd Patricia L, Nyongesa Paul, Esamai Fabian, Bucher Sherri L, Goco Norman, Hemingway-Foday Jennifer J, Babineau Denise C, McClure Elizabeth M, Silver Robert M, Derman Richard J, Carlo Waldemar A, ASPIRIN Study Group Collaborators
Аннотация
DESIGN: Post hoc analysis of a randomized controlled trial.
SETTING: Hospitals in low-resource settings in Africa, Asia and Latin America.
POPULATION: Outcomes were obtained for 11 908/11943 women at 6 0/7 to 13 6/7 weeks' GA randomized.
METHODS: Women received prepackaged two-week medication allotments. Adherence was assessed by pill counts every 2 weeks. Estimated relative risk and 95% confidence interval data for each outcome at each GA of treatment initiation weeks were obtained by fitting a Poisson model to each outcome, adjusting for site, treatment arm and GA at treatment initiation.
MAIN OUTCOMES MEASURES: The primary outcome was PTD. Secondary outcomes included PTD < 34 weeks and perinatal mortality including analysis by region.
RESULTS: The median gestational age at treatment initiation was 10.1 weeks (IQR 8.6, 12.0). 85.5% of the mothers had over 90% adherence to treatment. For each 1 week increase of GA at treatment initiation, the treatment risk ratio did not change for PTD [RR 0.97 (95% CI, 0.93, 1.02)], PTD < 34 weeks [< 0.98 (0.89, 1.07)] or perinatal mortality [1.04 (0.96, 1.12)], with no evidence of effect modification. For each 5% increase in adherence, the treatment risk ratio did not change for PTD [1.01 (0.99, 1.04)], PTD < 34 weeks [< 0.99 (0.95, 1.03)] or perinatal mortality [1.02 (0.98, 1.06)], indicating no meaningful interaction with adherence. There was no effect modification by region.
CONCLUSIONS: This analysis shows that the results of PTD, PTD < 34 weeks and perinatal mortality were not dependent on the timing of the initiation or adherence to treatment.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02409680.