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The lack of human data available to inform evidence-based treatment for illness during pregnancy has led to calls for greater inclusion of pregnant women in research, but the extent of their current representation is poorly characterized. Our objective was to measure the current exclusion of pregnant women from industry-sponsored clinical trials as a baseline for future comparison.We compiled data from studies enrolling women of childbearing potential posted on www.ClinicalTrials.gov between 1 October 2011 and 31 January 2012. The review was limited to open United States-based phase IV interventional studies sponsored by the pharmaceutical industry evaluating treatment of conditions that may be experienced by but are not limited to pregnant women and did not involve a medication classified as potentially teratogenic. If there was no mention of pregnancy in the inclusion or exclusion criteria, we contacted a study representative to confirm that pregnant women could be enrolled.Of 558 qualifying industry-sponsored studies, five (1%) were designed specifically for pregnant women. Of 367 phase IV clinical trials with verified inclusion and exclusion criteria, 348 (95%) excluded pregnant women and 19 (5%) did not.We found the exclusion of pregnant women from industry-sponsored clinical trials to be common practice. Moving beyond reflexive exclusion and developing thoughtful criteria for inclusion of pregnant women in clinical research would likely advance the evidence base to inform treatment decisions during pregnancy and lead to better health outcomes for women and children.

"Therapeutic" bed rest continues to be used widely, despite evidence of no benefit and known harms. In this commentary, we summarize the Cochrane reviews of bed rest and propose an ethical argument for discontinuing this practice. Cochrane systematic reviews do not support "therapeutic" bed rest for threatened abortion, hypertension, preeclampsia, preterm birth, multiple gestations, or impaired fetal growth. This assessment has been echoed in other comprehensive reviews. Prescribing bed rest is inconsistent with the ethical principles of autonomy, beneficence, and justice. Hence, if bed rest is to be used, it should be only within a formal clinical trial.

Patients making difficult choices among therapeutic options often ask their physicians what they would do if they were in the same situation. When faced with that question, physicians might be concerned that a direct answer could infringe on a patient's autonomy by substituting the physician's unique worldview or experience for their patients'. However, refusing to answer the question might lead a patient to feel unsupported at a difficult time. In this article we describe an approach that allows a physician to contribute to the patient's decision without inadvertently being coercive. That approach requires physicians to meaningfully shape therapeutic options, and assist patients in making difficult decisions. It is dependent on the physician being aware of the role of both their patients' values, and health values (eg, autonomy, futility) in decision making. It also requires an awareness of the force of language, both stated and implied, in shaping a patient's choice. To make a good decision, women need more than accurate information. They also need to be supported and sense empathy and understanding from their physicians and feel cared for. Although the facts (benefits and harms related to any given choice) are a necessary component of counseling, without discussion of values, they do not lead to a truly informed decision.

Assessing, communicating, and managing risk are among the most challenging tasks in the practice of medicine and are particularly difficult in the context of pregnancy. We analyze common scenarios in medical decision making around pregnancy, from reproductive health policy and clinical care to research protections. We describe three tendencies in these scenarios: 1) to consider the probabilities of undesirable outcomes alone, in isolation from women's values and social contexts, as determinative of individual clinical decisions and health policy; 2) to regard any risk to the fetus, including incremental risks that would in other contexts be regarded as acceptable, as trumping considerations that may be substantially more important to the wellbeing of the pregnant woman; and 3) to focus on the risks associated with undertaking medical interventions during pregnancy to the exclusion of demonstrable risks to both woman and fetus of failing to intervene. These tendencies in the perception, communication, and management of risk can lead to care that is neither evidence-based nor patient-centered, often to the detriment of both women and infants.