Pregnancy Clinical Trial
Official title:
Repercussion of Maternal Lifestyle on Obstetric and Neonatal Outcomes
tPA has a pivotal role in placentation, mediationg activation of growth factors, such as
vascular endothelial growth factor and brain-derived neurotrophic factor, degradation of
extracellular matrix and basement membrane (directly or through activation of matrix
metalloproteinases) and formation of hemidesmosomes.
A high-carbohydrate intake combined with lack of physical activity provides a strong
stimulus for maternal insulin production. In this scenario, either β-cells are dysfunctional
and diabetes supervenes, or excessive amounts of insulin are produced, providing
pathological stimulation of PAI-1 synthesis. Given that PAI-1 is a major tPA inhibitor,
PAI-1 excess may affect placentation, increasing the risk of first trimester losses, preterm
deliveries and intrauterine growth restriction.
Our hypothesis was that prematurity was not the cause of neonatal hypoglycemia, but a
parallel occurrence of a strong stimulus for maternal, fetal and neonatal production of
insulin.
In an observational study, we sought to determine whether markers of hyperinsulinemia or
situations that increase maternal insulin requirements would increase the risk of neonatal
hypoglycemia. Mothers were selected if they had grade III obesity, acanthosis nigricans
(surrogates of chronic maternal hyperinsulinemia), any invasive bacterial infection or if
they had used corticosteroid within seven days before delivery (surrogates of subacute
insulin resistance), if they reported to have consumed a high-glycemic index diet within 24
hours before delivery or if they were physically inactive within 24 hours before delivery
(conditions that could increase maternal insulin requirements close to delivery).
Based on the finding that that the risk of neonatal hypoglycemia increased fivefold with
inactivity (95% CI: 2-11, P <0.001), 11-fold with high-carbohydrate intake (95% CI: 4-24, P
<0.001) and 329-fold with both risk factors (95% CI: 32-3362, P <0.001), next we have
evaluated how a protocol combining exercises and a balanced diet throughout pregnancy
influences maternal and neonatal outcomes. One of the outcomes analyzed was neonatal
hypoglycemia.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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