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Completed

NCT Number: NCT01409382

Maternal Lifestyle and Neonatal Hypoglycemia

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.

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Key information

Conditions

Hyperinsulinemia Abortion, Habitual Abortion, Spontaneous Behavior Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Hyperinsulinism Hypoglycemia Metabolic Diseases Miscarriages Motor Activity Nutritional and Metabolic Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Pregnancy Complications Premature Birth Sedentary Behavior Sedentary Lifestyle Urogenital Diseases

Age range

Up to 40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Federal dos Servidores do Estado

Rio de Janeiro, 20221-903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Daily brisk walking plus a carbohydrate-restricted diet

Behavioral

Daily brisk walking at moderate speed (4 km/h) for at least 40 minutes per day, 7 days a week. Patients will be recommended to avoid high-glycemic index meals (such as snacks, candies, fiber-free juices and sugar-sweetened beverages), and to eat at least two daily servings of meat, poultry, fish (e.g. 2 g/kg) or other protein-rich food, starting when they decided to get pregnant and continuing until delivery. Recommendations will be emphasised at every appointment. Antidepressants will not be discontinued in both groups, but patients on paroxetine and sertraline, will be switched to fluoxetine.

Primary outcomes

  1. Neonatal Hypoglycemia

    Time frame: 1, 2 and 4 h after birth.

    Any glucose level equal or below 40mg/dL at 1, 2 or 4 h after birth, obtained by heelstick.

Secondary outcomes

  1. Refractory Hypoglycemia

    Time frame: One hour after feeding or after intravenous dextrose

    Any glucose level ≤ 40/dL at 1, 2 or 4 h:

    • Neonates with hypoglycemia (glucose level equal or below 40 mg/dL at 1, 2 or 4 h) will be offered milk. Neonates unable to suckle, will be treated with intravenous dextrose for one hour.
    • A new heel stick blood sample will be drawn to assess glucose levels.
    • Neonates with persistent hypoglycemia will be considered as refractory hypoglycemia.

Other outcomes

  1. Pregnancy and Neonatal Outcomes

    Time frame: Three years

    Early miscarriages, 2nd and 3rd trimester losses, preterm deliveries, take-home babies, neonatal hypoglycemia: number of babies

Sponsors and collaborators

Lead sponsor

Hospital dos Servidores do Estado do Rio de Janeiro

Other Gov

Collaborators

  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Registry information

Official study title

Repercussion of Maternal Lifestyle on Obstetric and Neonatal Outcomes

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Aug 4, 2011
Registry last updated
Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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