ORCHARD: a model for conducting pragmatic randomised trials in pregnancy

Excerpt

There is an unmet need for high quality clinical trials in pregnancy. Pregnant individuals receive outdated and less effective therapies, due to efficacy and safety requirements for licensing in pregnancy. Forty-six percent of pregnant women with moderate-severe chronic kidney disease (CKD) will require dialysis or lose at least 25% of kidney function within six months of delivery with no development of preventative treatments [1‐4] To our knowledge, there have been no randomised controlled trials to reduce adverse outcomes in pregnancy for women with CKD since 1995 [5], and those with renal impairment are frequently excluded from studies. Concerns about potential teratogenicity and randomisation may hinder both clinicians and patients from participating in pregnancy trials, but the substantial risk associated with entering pregnancy with pre-existing disease without robust evidence to guide management cannot be underestimated. The ORCHARD-BEET trial was developed to test feasibility of recruitment to a trial of women with CKD in pregnancy and to assess the impact of nitric oxide augmentation in CKD pregnancy (Observational cohort with embedded Randomised Controlled trials to study pregnancy-Associated progression of Renal Disease—A Feasibility Study of Dietary Nitrate (BEETroot juice) to protect kidney function in pregnant women with Chronic Kidney Disease). …