TY - JOUR
T1 - Myo-inositol Supplementation to Prevent Pregnancy Complications in Polycystic Ovary Syndrome
T2 - A Randomized Clinical Trial
AU - van der Wel, Anne W.T.
AU - Frank, Chryselle M.C.
AU - Bout-Rebel, Rebekka
AU - Duijnhoven, Ruben G.
AU - van Bree, Bo E.
AU - Valkenburg, Olivier
AU - Al-Nasiry, Salwan
AU - van Oppenraaij, Robbert H.F.
AU - Vogelvang, Tatjana E.
AU - Westerhuis, Michelle E.M.H.
AU - van de Nieuwenhof, Hedwig P.
AU - Gielen, Susanne C.J.P.
AU - Bandell, Myrthe L.
AU - Bekker, Mireille N.
AU - Wouters, Maurice G.A.J.
AU - Mijatovic, Velja
AU - Franx, Arie
AU - Lambalk, Cornelis B.
AU - Broekmans, Frank J.M.
AU - de Weerd, Sabina
AU - Gerards, Jet M.H.
AU - Baalman, Jelle H.
AU - Van Disseldorp, Jeroen
AU - Langenveld, Josje
AU - Gunning, Marlise N.
AU - Frederix, Geert W.J.
AU - Painter, Rebecca C.
AU - Fauser, Bart C.J.M.
AU - Laven, Joop S.E.
AU - van Rijn, Bas B.
N1 - Publisher Copyright:
© 2025 American Medical Association.
PY - 2025/10/7
Y1 - 2025/10/7
N2 - Importance: Pregnant individuals with polycystic ovary syndrome (PCOS) present with a higher risk of pregnancy complications, including gestational diabetes, preeclampsia, and preterm birth. Myo-inositol supplementation may reduce these risks. Objective: To determine whether daily supplementation with myo-inositol during pregnancy among individuals with PCOS reduces the risk of a composite outcome of gestational diabetes, preeclampsia, and preterm birth. Design, Setting, and Participants: This double-blind, placebo-controlled, randomized trial was conducted at 13 hospitals in the Netherlands. Pregnant individuals with PCOS who were between 8 and 16 weeks' gestation were enrolled between June 2019 and March 2023. Final follow-up was complete on December 27, 2023. Analyses were conducted July 2024. Interventions: Participants were randomized on a 1:1 basis to receive sachets with either myo-inositol, 2 g, with 0.2 mg of folic acid twice daily (n = 230) or matching placebo with 0.2 mg of folic acid only (n = 234) until delivery. Main Outcomes and Measures: The primary outcome was a composite of gestational diabetes, preeclampsia, or preterm birth (before 37 weeks' gestation). Results: Among 464 participants, the mean (SD) age was 31.5 (3.8) years; 18 participants (3.9%) reported Asian race and 395 (86.1%) reported White race. The prevalence of biochemical hyperandrogenism was higher at baseline in the myo-inositol group than the placebo group (29.0% [53 of 180] vs 18.5% [37 of 193]). A primary outcome event occurred in 25.0% (n = 56) of participants in the myo-inositol group and 26.8% (n = 61) in the placebo group (relative risk, 0.93 [95% CI, 0.68-1.28]; P =.67). Conclusions and Relevance: Myo-inositol supplementation during pregnancy did not reduce the incidence of a composite of gestational diabetes, preeclampsia, or preterm birth in patients with PCOS. Trial Registration: onderzoekmetmensen.nl Identifier: NL67329.078.18.
AB - Importance: Pregnant individuals with polycystic ovary syndrome (PCOS) present with a higher risk of pregnancy complications, including gestational diabetes, preeclampsia, and preterm birth. Myo-inositol supplementation may reduce these risks. Objective: To determine whether daily supplementation with myo-inositol during pregnancy among individuals with PCOS reduces the risk of a composite outcome of gestational diabetes, preeclampsia, and preterm birth. Design, Setting, and Participants: This double-blind, placebo-controlled, randomized trial was conducted at 13 hospitals in the Netherlands. Pregnant individuals with PCOS who were between 8 and 16 weeks' gestation were enrolled between June 2019 and March 2023. Final follow-up was complete on December 27, 2023. Analyses were conducted July 2024. Interventions: Participants were randomized on a 1:1 basis to receive sachets with either myo-inositol, 2 g, with 0.2 mg of folic acid twice daily (n = 230) or matching placebo with 0.2 mg of folic acid only (n = 234) until delivery. Main Outcomes and Measures: The primary outcome was a composite of gestational diabetes, preeclampsia, or preterm birth (before 37 weeks' gestation). Results: Among 464 participants, the mean (SD) age was 31.5 (3.8) years; 18 participants (3.9%) reported Asian race and 395 (86.1%) reported White race. The prevalence of biochemical hyperandrogenism was higher at baseline in the myo-inositol group than the placebo group (29.0% [53 of 180] vs 18.5% [37 of 193]). A primary outcome event occurred in 25.0% (n = 56) of participants in the myo-inositol group and 26.8% (n = 61) in the placebo group (relative risk, 0.93 [95% CI, 0.68-1.28]; P =.67). Conclusions and Relevance: Myo-inositol supplementation during pregnancy did not reduce the incidence of a composite of gestational diabetes, preeclampsia, or preterm birth in patients with PCOS. Trial Registration: onderzoekmetmensen.nl Identifier: NL67329.078.18.
UR - https://www.scopus.com/pages/publications/105018021204
U2 - 10.1001/jama.2025.13668
DO - 10.1001/jama.2025.13668
M3 - Article
C2 - 40920401
AN - SCOPUS:105018021204
SN - 0098-7484
VL - 334
SP - 1151
EP - 1159
JO - JAMA
JF - JAMA
IS - 13
ER -
