Myo-Inositol, Probiotics, and Micronutrient Supplementation From Preconception for Glycemia in Pregnancy: NiPPeR International Multicenter Double-Blind Randomized Controlled Trial
Year: 2021
Type: other
Abstract: Objective: Better preconception metabolic and nutritional health are hypothesized to promote gestational normoglycemia and reduce preterm birth, but evidence supporting improved outcomes with nutritional supplementation starting preconception is limited. Research Design and Methods: Double-blind randomized controlled trial recruited from the community 1729 UK, Singapore and New Zealand women aged 18-38 years planning conception. We investigated if a nutritional formulation containing myo-inositol, probiotics and multiple micronutrients (intervention), compared with a standard micronutrient supplement (control), taken preconception and throughout pregnancy, could improve pregnancy outcomes. The primary outcome was combined fasting, 1-hour and 2-hour post-load glycemia (28 weeks’ gestation oral glucose tolerance test). Results: Between 2015-2017, participants were randomized to control (n=859) or intervention (n=870); 585 conceived within 1-year and completed the primary outcome (295 intervention, 290 control). In an intention-to-treat analysis adjusting for site, ethnicity and preconception glycemia with pre-specified p<0.017 for multiplicity, there were no differences in gestational fasting, 1-hour and 2-hour glycemia between groups (β [95%CI] loge mmol/L intervention versus control: -0·004 [-0·018, 0·011], 0·025 [-0·014, 0·064], 0·040 [0·004, 0·077], respectively). Between the intervention and control groups there were no significant differences in gestational diabetes (24·8% versus 22·6%, adjusted risk ratio aRR=1·22 [0·92, 1·62]), birthweight (adjusted β=0·05kg [-0·03, 0·13]), or gestational age at birth (mean 39.3 versus 39.2 weeks, adjusted β=0·20 [-0·06, 0·46]), but there were fewer preterm births (5·8% versus 9·2%, aRR=0·43 [0·22, 0·82]) adjusting for pre-specified covariates. Conclusions: Supplementation with myo-inositol, probiotics and micronutrients preconception and in pregnancy did not lower gestational glycemia, but did reduce preterm birth.
Language: English
Subfield: Obstetrics and Gynecology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
OpenAlex ID: W4239025771