Should pregnant women be excluded from a community-based lifestyle intervention trial? A case study

Abstract Kerala, the southernmost Indian state, is known as the diabetes capital of the country. A community-based lifestyle modification program was implemented in the rural areas of Kerala, India, to assess effectiveness in reducing the incidence of type 2 diabetes mellitus (T2DM) among individuals at high risk. High-risk individuals for T2DM were identified through home screening and enrolled into the program after an oral glucose tolerance test to rule out T2DM. Pregnant women were excluded from participation in the trial without justification. An analysis is offered to show that exclusion in this case compromised the ethical requirements of fairness and favorable risk-benefit ratio: specifically, pregnant women were deprived of the benefits of screening for high-risk status and subsequent potential involvement in the lifestyle modification intervention, an effective preventive strategy. Exclusion of pregnant women from translational and implementation research with known benefits over risk violates several ethical principles and further limits the exploration and advancement of research for future disease prevention in the population at large. Clearer guidelines on minimal risk and benefit need to be established in order to facilitate research that is beneficial to pregnant women and the developing fetus.