Медицинская библиотека · JAMA · 2025

Myo-inositol Supplementation to Prevent Pregnancy Complications in Polycystic Ovary Syndrome: A Randomized Clinical Trial.

van der Wel Anne W T, Frank Chryselle M C, Bout-Rebel Rebekka, Duijnhoven Ruben G, van Bree Bo E, Valkenburg Olivier, Al-Nasiry Salwan, van Oppenraaij Robbert H F, Vogelvang Tatjana E, Westerhuis Michelle E M H, van de Nieuwenhof Hedwig P, Gielen Susanne C J P, Bandell Myrthe L, Bekker Mireille N, Wouters Maurice G A J, Mijatovic Velja, Franx Arie, Lambalk Cornelis B, Broekmans Frank J M, de Weerd Sabina, Gerards Jet M H, Baalman Jelle H, van Disseldorp Jeroen, Langenveld Josje, Gunning Marlise N, Frederix Geert W J, Painter Rebecca C, Fauser Bart C J M, Laven Joop S E, van Rijn Bas B

СтатьяМногоцентровое исследованиеРандомизированное исследованиеПеревод в очереди

Аннотация

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.

Для цитирования: van der Wel Anne W T, Frank Chryselle M C, Bout-Rebel Rebekka, Duijnhoven Ruben G, van Bree Bo E, Valkenburg Olivier, Al-Nasiry Salwan, van Oppenraaij Robbert H F, Vogelvang Tatjana E, Westerhuis Michelle E M H, van de Nieuwenhof Hedwig P, Gielen Susanne C J P, Bandell Myrthe L, Bekker Mireille N, Wouters Maurice G A J, Mijatovic Velja, Franx Arie, Lambalk Cornelis B, Broekmans Frank J M, de Weerd Sabina, Gerards Jet M H, Baalman Jelle H, van Disseldorp Jeroen, Langenveld Josje, Gunning Marlise N, Frederix Geert W J, Painter Rebecca C, Fauser Bart C J M, Laven Joop S E, van Rijn Bas B. Myo-inositol Supplementation to Prevent Pregnancy Complications in Polycystic Ovary Syndrome: A Randomized Clinical Trial.. JAMA. 2025. DOI: 10.1001/jama.2025.13668.

Предметные рубрики MeSH

Adult Female Humans Pregnancy Diabetes, Gestational Dietary Supplements Double-Blind Method Folic Acid Inositol Netherlands Polycystic Ovary Syndrome Pre-Eclampsia Premature Birth Treatment Outcome Vitamin B Complex

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