Daily myo-inositol supplementation during pregnancy did not reduce major complications among patients with polycystic ovary syndrome, according to a randomized clinical trial in the Netherlands.
Among 464 patients, 25% of those assigned to myo-inositol experienced a composite outcome of gestational diabetes, preeclampsia, or preterm birth compared with 27% in the placebo group. Individual outcomes were also similar. Gestational diabetes was diagnosed in 17% of the myo-inositol group vs 16% in the placebo group, preeclampsia in 2% vs 5%, and preterm birth before 37 weeks in 8% vs 9%, respectively.
Overall cesarean delivery rates were nearly identical, though planned cesarean deliveries showed a significantly lower rate in the myo-inositol group. Neonatal outcomes, including gestational age at delivery, Apgar scores, and neonatal intensive care admissions, showed no meaningful differences.
The MYPP trial was conducted at 13 hospitals from June 2019 to March 2023, with follow-up through December 2023, enrolled patients 8 and 16 weeks’ gestation and had a confirmed diagnosis of polycystic ovary syndrome (PCOS). They were randomized to receive sachets containing 2 g of myo-inositol plus 0.2 mg folic acid twice daily or placebo sachets containing folic acid only, continuing until delivery. Patients with preexisting type 1 or type 2 diabetes, kidney failure, or use of hypoglycemic agents were excluded.
Adherence was moderate, with about three-quarters in myo-inositol and placebo groups, consuming at least 60% of assigned sachets. However, "good adherence" (at least 80% consumption) was achieved by only 40% and 32% respectively. Adverse events were infrequent and occurred at similar rates.
The researchers noted limitations, including higher rates of biochemical hyperandrogenism at baseline in the myo-inositol group (30% vs 19%) and lower-than-expected overall event rates (26% vs the anticipated 33%), which reduced statistical power.
“The lower observed event rate may reflect the influence of trial participation itself, including closer monitoring, structured follow-up, and increased adherence to clinical recommendations in both study groups,” said Anne W. T. van der Wel, MD, Department of Obstetrics and Gynecology, Amsterdam University Medical Center, and colleagues.
Full disclosures can be found in the study.
Source: JAMA
