Esomeprazole for the Prevention of Preeclampsia

Summary

Participation Requirements

Description

This is a randomized double-blinded placebo-controlled intervention trial investigating preeclampsia, defined according to the National Institute of Clinical Excellence (NICE). The population of interest involves women attending the study hospital for antenatal care and delivery with a risk for deve...

This is a randomized double-blinded placebo-controlled intervention trial investigating preeclampsia, defined according to the National Institute of Clinical Excellence (NICE). The population of interest involves women attending the study hospital for antenatal care and delivery with a risk for developing preeclampsia. The intervention involves randomization to oral esomeprazole tablets40 mg or identical placebo tablet from recruitment until delivery. Randomization is achieved using computational random allocation, and both participants and researchers will be blinded to the intervention given. Calculation of the sample size considers that the incidence of preeclampsia is 10% in the population of interest. To detect a 50% reduction in incidence (with 80% power, two-sided p < 0.05), 450 women are required in each group with a 1:1 ratio.

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