Clinical trial NCT01409382: Maternal Lifestyle and Neonatal Hypoglycemia
Official title: Repercussion of Maternal Lifestyle on Obstetric and Neonatal Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperinsulinemia
Miscarriages
Pregnancy
Sedentary Lifestyle
Hypoglycemia
Keywords: neonatal hypoglycemia
pregnancy
physical activity
sedentary lifestyle
high-glycemic index diet
take-home baby
recurrent miscarriages
preterm delivery
Lead sponsor: Hospital dos Servidores do Estado do Rio de Janeiro
Sponsor class: OTHER_GOV
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2011-08-04
Enrollment: 480
Sex: ALL
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria: recurrent early unexplained miscarriages Exclusion criteria: (i) antiphospholipid antibodies, (ii) second- or third-trimester losses, (iii) multiple pregnancy, (iv) anatomical abnormalities that could increase the risk of early miscarriages, (iv) any condition requiring a priori anticoagulation, (v) protocol violation.

Primary outcomes:
measure: Neonatal Hypoglycemia
timeFrame: 1, 2 and 4 h after birth.
Secondary outcomes:
measure: Refractory Hypoglycemia
timeFrame: One hour after feeding or after intravenous dextrose
Other outcomes:
measure: Pregnancy and Neonatal Outcomes
timeFrame: Three years
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Federal dos Servidores do Estado
state: RJ
Study officials:
affiliation: Hospital dos Servidores do Estado, RJ; Universidade Federal do Rio de Janeiro
name: Maria A Sayeg-Porto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Gama Filho; COPPE/UFRJ
name: Paulo R Benchimol-Barbosa, MD, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital dos Servidores do Estado, RJ
name: Silvia Hoirisch-Clapauch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hoirisch-Clapauch S, Porto MAS. Early neonatal hypoglycemia prediction according to maternal parameters. Thrombosis Research 131(1): S96, 2013.