MYPP trial: Myo-inositol supplementation to prevent pregnancy complications in women with polycystic ovary syndrome, study protocol for a multicenter, double-blind, randomized controlled trial
Abstract
ABSTRACT:
Introduction: Pregnant women with polycystic ovary syndrome (PCOS) have an increased risk of gestational diabetes mellitus (GDM), preeclampsia and preterm birth, and their offspring are more likely to have an abnormal birth weight and require hospitalization. Current preventive strategies to reduce the rate of pregnancy complications associated with PCOS have ineffective. Myo-inositol supplementation has shown promising clinical benefit in preventing adverse outcomes in individuals with obesity and PCOS-related disorders. Recent randomized controlled trials using daily supplementation with 4 grams of myo-inositol during pregnancy estimated a relative reduction of up to 65% for GDM and preterm delivery.(1–7) These studies included both obese patients and patients with normal body weight. From these trials, post-hoc analysis suggested similar, or even greater, reductions in the sub group of women with PCOS.(8) However, no randomized controlled trials have been conducted to evaluate the potential benefit of myo-inositol supplementation in preventing pregnancy complications in these women.
Methods and analysis: This is a prospective, multicenter, double-blind, randomized controlled trial to study the clinical effectiveness and cost-effectiveness of myo-inositol supplementation to prevent pregnancy among women with PCOS. Recruitment will set out to include 464 individuals with PCOS between 8+0 and 16+0 weeks of pregnancy, who are then randomized in a 1:1 ratio to either…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 464 participants or records.
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