At baseline, the median age overall was about 30 years, and the median body mass index was about 28 kg/m2. Patients were at a median 74 days gestational age of pregnancy at randomization, and 53%-61% of patients were on metformin at the time of conception, with no significant difference between the metformin and placebo group.
A little less than half (40%-46%) of participants had a spontaneous conception, and most participants (56%-59%) had no prior term deliveries. Participants were overwhelmingly (91%-97%) white and Nordic.
There were no serious maternal, fetal, or neonatal safety signals in either study group.
The study followed the earlier PregMet study, which also tracked use of metformin in pregnancy for women with PCOS.