Abstract
BACKGROUND: Current approaches for establishing public health guidelines on the recommended range of weight gain in pregnancy are subjective and nonsystematic. OBJECTIVE: In this article, we outline how decision-making on gestational weight-gain guidelines could be aided by quantitative approaches used in noninferiority trials. DESIGN: We reviewed the theoretical application of noninferiority margins to pregnancy weight-gain guidelines. A worked example illustrated the selection of the recommended range of pregnancy weight gain in women who delivered at the Magee-Womens Hospital, Pittsburgh, PA, in 2003-2010 by identifying weight-gain z scores in which risk of unplanned cesarean delivery, preterm birth, small-for-gestational-age infant, and large-for-gestational-age infant were not meaningfully increased (based on noninferiority margins of 10% and 20%). RESULTS: In normal-weight women, lowest risk of adverse perinatal outcome was observed at a weight-gain z score of -0.2 SDs. With a noninferiority margin of 20%, risks of adverse outcome were not meaningfully increased from the -0.2-SD reference value between z scores of -0.97 and +0.33 SDs (which corresponded to 11.3-18.4 kg). In overweight women, the recommended range was much broader: -2.11 to +0.29 SDs (4.4-18.1 kg). CONCLUSION: The new approach illustrated in this article has a number of advantages over current methods for establishing pregnancy weight-gain guidelines because it is systematic, it is reproducible, and it provides a tool for policy makers to derive guidelines that explicitly reflect values at which risk of adverse outcome becomes meaningfully increased.