Calcium Aspirin Preeclampsia Early Prevention and Response (CASPER)
trial in Blantyre, Malawi: A double blinded cluster randomised trial.
Abstract
Objective: To assess the efficacy of early pregnancy calcium and low
dose of aspirin (LDA) in preventing preeclampsia and eclampsia in
Blantyre, Malawi. Design: This was a double-blind cluster randomized
controlled trial. Setting: Four urban health centers and Queen Elizabeth
Central Hospital (QECH) as a referral site in Blantyre, Malawi.
Population or sample: A total of 306 women at high-risk of preeclampsia
were recruited. Methods: Women were assigned to LDA (150mg/day) or
placebo from 12 to 16 weeks until 34 weeks of gestation in clusters. All
women were additionally given calcium 1 gram/day. The intention to treat
analysis and adherence analysis was conducted. Main outcome measure: The
rate of preeclampsia. Results: A total of 39 women were lost to follow
up and 1 withdrew consent. Data for 266 women was available for
analysis. Overall preeclampsia occurred in 15.8% (42/266) and eclampsia
in 2.3% (6/266) of all women. There was no statistically significant
difference in the rate of preeclampsia between the LDA group 19%
(26/135) and placebo group 14% (16/131) (adjusted OR 1.01 95%CI
0.34-3.04, p=0.135). No statistically significant difference was
observed in the secondary maternal and neonatal outcomes. The overall
adherence was 69%. Conclusion: Treatment with LDA and calcium in women
at risk of preeclampsia resulted in no difference in the rate of
preeclampsia, nor cesarean section rates, or important neonatal outcomes
in Malawi. Funding: The study was funded by PEARLS at the
Heart Research Institute, Sydney, Australia. It was registered by Pan
African Clinical Trial
Registry([http://www.pactr.org/](http://www.pactr.org/))
registration number PACTR202108825067735.