Objective
Women often hesitate to take medications in pregnancy due to fears of perceived potential fetal damage. The authors’ objective is to identify the determinants of adherence to delayed release doxylamine-pyridoxine (Diclectin®) in patients with nausea and vomiting of pregnancy (NVP).
Methods
The authors performed a pre-specified secondary analysis of a multicenter double blind randomized controlled trial of Diclectin® vs. placebo for the treatment of NVP. Data on adherence to study medication were collected in all patients. The primary outcome of this analysis was adherence with study medication, which was determined by pill counting and patient diaries. The treatment regimen in the original trial was not fixed and depended on patient’s symptoms. There was no difference in the adherence rates between subjects in the Diclectin® or placebo arms of the study, so the 2 arms were analyzed as one cohort. The degree of adherence was analyzed in the various subgroups. Subsequently, a multiple linear regression model was constructed to identify predictors to adherence.
Results
258 women were included in this analysis. There was no difference in adherence rates according to ethnicity, race or the presence of adverse events. Gravidity, average number of prescribed tablets per day, site of enrollment, and change in NVP severity measured by the pregnancy unique-quantification of emesis (PUQE) score were associated with adherence. In multivariable analysis, average number of tablets per day, change in PUQE, number of treatment days, site of enrollment were significantly predictive of adherence, with the former being negatively correlated.
Conclusion
adherence to antinauseants for NVP is affected by number of tablets prescribed per day, and treatment duration and effectiveness.