<b>Objective:</b> 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.
<p><b>Research Design
and Methods:</b> 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).</p>
<p><b>Results</b>: 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] log<sub>e</sub> 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.</p>
<p><b>Conclusions: </b>Supplementation with
myo-inositol, probiotics and micronutrients preconception and in pregnancy did
not lower gestational glycemia, but did reduce preterm birth. </p>
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