Myo-inositol Supplementation to Prevent Pregnancy Complications in Polycystic Ovary Syndrome: A Randomized Clinical Trial
Primary result · Composite of gestational diabetes, preeclampsia, or preterm birthResult — go to the resultRelative risk 0.93 95% CI 0.68–1.28Authors' conclusion
Myo-inositol supplementation during pregnancy did not reduce the incidence of a composite of gestational diabetes, preeclampsia, or preterm birth in patients with PCOS.
Study context
- Population
- Pregnant individuals with polycystic ovary syndrome (PCOS) between 8 and 16 weeks' gestation, 13 hospitals in the Netherlands; mean (SD) age 31.5 (3.8) yearsrandomized 1:1
- Participants
- 464 individuals
- Comparison
- Myo-inositol 2 g + folic acid 0.2 mg twice daily vs placebo + folic acid 0.2 mg
- Myo-inositoln = 230
- Placebon = 234reference
- Primary endpoint
- Composite of:
- Gestational diabetes
- Preeclampsia
- Preterm birth (before 37 weeks' gestation)
Methodological detailsdouble-blind, placebo-controlled, 13 hospitals in the Netherlands, Enrolled June 2019 to March 2023; final follow-up December 27, 2023
- Double-blind
- Placebo-controlled
- 13 hospitals in the Netherlands
- Enrolled June 2019 to March 2023; final follow-up December 27, 2023
Primary result
As reported in the abstract
Composite of:
- Gestational diabetes
- Preeclampsia
- Preterm birth
Relative risk
0.93
95% CI 0.68–1.28
P = 0.67
Events by treatment group
Myo-inositolvs Placebo
RR 0.93 (95% CI 0.68–1.28); P = 0.67
Further findings
Biochemical hyperandrogenism at baseline
- Biochemical hyperandrogenism at baseline: 53 of 180 vs 37 of 193
Original publication
Myo-inositol Supplementation to Prevent Pregnancy Complications in Polycystic Ovary Syndrome: A Randomized Clinical Trial. JAMA. Published 7 October 2025. doi:10.
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