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The problem
Intervention: Mosapride citrate hydrate exposure during the first trimester of pregnancy
Who it was tested with: Pregnant women who consulted teratology information centers in Japan between 1988 and 2017; exposed group n=104 infants, control group n=1,693 infants.
Children or communities are compared with a group that did not receive the intervention, or followed over years. This is the design that best separates what the intervention did from everything else that changed.
"We conducted a prospective cohort study using data from two teratology information centers in Japan. Pregnant women who consulted these centers between April 1988 and December 2017 were included. The incidence of major congenital anomalies was compared between women exposed to mosapride during the first trimester and a control group." This prospective design with a defined comparison group and measured outcomes (congenital anomalies, pregnancy complications) meets criteria for experimental evidence tier.
Sample size of exposed group may be insufficient to detect small to moderate increases in rare anomalies; cannot exclude small increases in risk; findings limited to Japanese population and first-trimester exposure period
Across countries and designs
1 study · 1 country
