Evidence map›Paper›PMID 40920401›Full record

Trial reportJAMA2025

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

Anne W T van der Wel, Chryselle M C Frank, Rebekka Bout-Rebel, Ruben G Duijnhoven, Bo E van Bree, Olivier Valkenburg, Salwan Al-Nasiry, Robbert H F van Oppenraaij, Tatjana E Vogelvang, Michelle E M H Westerhuis and 20 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in JAMA, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. Review
  5. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

30 authors.

Anne W T van der WelDepartment of Obstetrics and Gynecology, Amsterdam University Medical Center location AMC, Amsterdam, the Netherlands.
Chryselle M C FrankDepartment of Obstetrics and Gynecology, University Medical Center Utrecht, Utrecht, the Netherlands.
Rebekka Bout-RebelDepartment of Obstetrics and Gynecology, Division of Reproductive Endocrinology & Infertility, Erasmus University Medical Center, Rotterdam, the Netherlands.
Ruben G DuijnhovenDepartment of Obstetrics and Gynecology, Amsterdam University Medical Center location AMC, Amsterdam, the Netherlands.
Bo E van BreeDepartment of Obstetrics and Gynecology, Maastricht University Medical Centre, Maastricht, the Netherlands.
Olivier ValkenburgDepartment of Obstetrics and Gynecology, Maastricht University Medical Centre, Maastricht, the Netherlands.
Salwan Al-NasiryDepartment of Obstetrics and Gynecology, Maastricht University Medical Centre, Maastricht, the Netherlands.
Robbert H F van OppenraaijDepartment of Obstetrics and Gynecology, Maasstad Hospital, Rotterdam, the Netherlands.
Tatjana E VogelvangDepartment of Obstetrics and Gynecology, Diakonessenhuis Utrecht, Utrecht, the Netherlands.
Michelle E M H WesterhuisDepartment of Obstetrics and Gynecology, Catharina Hospital, Eindhoven, the Netherlands.
Hedwig P van de NieuwenhofDepartment of Obstetrics and Gynecology, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.
Susanne C J P GielenDepartment of Obstetrics and Gynecology, Franciscus Gasthuis and Vlietland, Rotterdam, the Netherlands.
Myrthe L BandellDepartment of Obstetrics and Gynecology, Albert Schweitzer Hospital, Dordrecht, the Netherlands.
Mireille N BekkerDepartment of Obstetrics and Gynecology, University Medical Center Utrecht, Utrecht, the Netherlands.
Maurice G A J WoutersDepartment of Obstetrics and Gynecology, Amsterdam University Medical Center location AMC, Amsterdam, the Netherlands.
Velja MijatovicAmsterdam Reproduction & Development Research Institute, Amsterdam, the Netherlands.
Arie FranxDepartment of Obstetrics and Gynecology, Division of Reproductive Endocrinology & Infertility, Erasmus University Medical Center, Rotterdam, the Netherlands.
Cornelis B LambalkAmsterdam Reproduction & Development Research Institute, Amsterdam, the Netherlands.
Frank J M BroekmansDepartment of Reproductive Medicine and Gynecology, University Medical Center Utrecht & University of Utrecht, Utrecht, the Netherlands.
Sabina de WeerdDepartment of Obstetrics and Gynecology, Albert Schweitzer Hospital, Dordrecht, the Netherlands.
Jet M H GerardsDepartment of Obstetrics and Gynecology, Diakonessenhuis Utrecht, Utrecht, the Netherlands.
Jelle H BaalmanDepartment of Obstetrics and Gynecology, Medisch Spectrum Twente, Enschede, the Netherlands.
Jeroen van DisseldorpDepartment of Obstetrics and Gynecology, Sint Antonius Hospital, Nieuwegein, the Netherlands.
Josje LangenveldDepartment of Obstetrics and Gynecology, Zuyderland MC, Heerlen, the Netherlands.
Marlise N GunningDepartment of Reproductive Medicine and Gynecology, University Medical Center Utrecht & University of Utrecht, Utrecht, the Netherlands.
Geert W J FrederixDepartment of Public Health, Julius Center Research Program Methodology, University Medical Centre Utrecht, Utrecht, the Netherlands.
Rebecca C PainterAmsterdam Reproduction & Development Research Institute, Amsterdam, the Netherlands.
Bart C J M FauserDepartment of Reproductive Medicine and Gynecology, University Medical Center Utrecht & University of Utrecht, Utrecht, the Netherlands.
Joop S E LavenDepartment of Obstetrics and Gynecology, Division of Reproductive Endocrinology & Infertility, Erasmus University Medical Center, Rotterdam, the Netherlands.
Bas B van RijnDepartment of Obstetrics and Gynecology, Máxima Medical Center, Veldhoven, the Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Diabetes, GestationalDietary SupplementsInositolPolycystic Ovary SyndromePre-EclampsiaPremature BirthVitamin B ComplexAdultDouble-Blind MethodFemaleFolic AcidHumansNetherlandsPregnancyTreatment OutcomeFolic AcidInositolVitamin B Complex

Identifiers

PMID40920401
PMCPMC12418221

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.