ephalic index is the ratio between head width, the biparietal diameter, and head length, the anteroposterior diameter. Cephalic index can be obtained through the use of a manual caliper, skull radiography, computed tomography, or three-dimensional computed tomographic imaging. Cephalic index is a key measure that guides management of positional plagiocephaly, which is occipital flattening because of time spent on the back in infancy. The effect of supine sleeping on molding of the occipital skull is greatest at 2 to 4 months of life, and often starts to resolve as the infant gains head control and becomes more mobile. Additional risk factors for plagiocephaly include male sex, first-born child, difficult delivery, multiple births, prematurity, and torticollis. 1 The majority of plagiocephaly can be treated with behavioral interventions such as repositioning and stretching. 2 However, in severe cases, this treatment may be inadequate, and without further intervention there is a risk of retained facial asymmetry and

OBJECTIVEWomen of childbearing potential are often excluded from participating in clinical trials owing to concerns about adverse fetal effects of treatment. This study aims to determine the prevalence of fertility-related exclusion criteria in clinical trials of type 2 diabetes medications and to determine whether these criteria are commensurate with drug risk.RESEARCH DESIGN AND METHODSClinicalTrials.gov was queried for trials of type 2 diabetes medications that were phase 2 or 3, were based in the U.S., and enrolled participants 18–40 years old. Six hundred eighty-eight trials met criteria. Information collected about each trial included enrollment, trial length, exclusion and inclusion criteria, trial sponsor, and pregnancy category of drug(s) administered.RESULTSMost studies (59%) included one or more fertility-related exclusion criteria, most often excluding current pregnancy (55%) and breast-feeding (44%). Trials of medications with increased fetal risk were not more restrictive: trials of category C drugs (evidence of fetal risks in animals) were less likely to exclude pregnancy compared with trials of category B drugs (no known human or animal fetal risks) (45.6% vs. 69.8%, odds ratio [OR] 0.37 [95% CI 0.20, 0.65], P = 0.0005) or to require contraceptive use (29.9% vs. 57.1%, OR 0.32 [95% CI 0.18, 0.56], P = 0.001).CONCLUSIONSIn clinical trials of type 2 diabetes medications, exclusion criteria affecting women of childbearing potential are often disproportionate to risk to the participant and fetus. These criteria have the potential to impede young women’s access to clinical trials and may hinder the acquisition of clinical knowledge critical for improving the care of women with diabetes.