Maternal Lifestyle and Neonatal Hypoglycemia

NCT01409382 | Completed Results DMC

• 1 other identifier: 000416-09-08-2010
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Neonatal Hypoglycemia

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

  1, 2 and 4 h after birth.

Secondary Outcomes (1)

• Refractory Hypoglycemia

  One hour after feeding or after intravenous dextrose

Other Outcomes (1)

• Pregnancy and Neonatal Outcomes

  Three years

Study Arms (2)

Lifestyle counseling

ACTIVE COMPARATOR

Daily brisk walking plus a carbohydrate-restricted diet

Behavioral: Daily brisk walking plus a carbohydrate-restricted diet

Standard follow-up

NO INTERVENTION

Prenatal care will proceed according to the routine.

Interventions

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.

Lifestyle counseling

Eligibility Criteria

• Age: Up to 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Hospital dos Servidores do Estado do Rio de Janeiro: lead
• Rio de Janeiro State Research Supporting Foundation (FAPERJ): collaborator

Study Sites (1)

Hospital Federal dos Servidores do Estado

Rio de Janeiro, Rio de Janeiro, 20221-903, Brazil

Location

Related Publications (1)

• Hoirisch-Clapauch S, Porto MAS. Early neonatal hypoglycemia prediction according to maternal parameters. Thrombosis Research 131(1): S96, 2013.

  RESULT

Related Links

• Data presented at the Women's Health Issues in Thrombosis and Hemostasis Meeting, in Vienna, February 2013.

MeSH Terms

Conditions

Hyperinsulinism; Abortion, Spontaneous; Sedentary Behavior; Hypoglycemia; Motor Activity; Abortion, Habitual; Premature Birth

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications

Results Point of Contact

• Title: Dr. Silvia Hoirisch-Clapauch
• Organization: Hospital Federal dos Servidores do Estado

sclapauch@gmail.com

55-21-999737500

Study Officials

• Maria A Sayeg-Porto, MD, PhD

  Hospital dos Servidores do Estado, RJ; Universidade Federal do Rio de Janeiro

  PRINCIPAL INVESTIGATOR

• Paulo R Benchimol-Barbosa, MD, DSc

  Universidade Gama Filho; COPPE/UFRJ

  PRINCIPAL INVESTIGATOR

• Silvia Hoirisch-Clapauch, MD

  Hospital dos Servidores do Estado, RJ

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 27, 2011
• First Posted: August 4, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: October 1, 2015
• Last Updated: September 29, 2016
• Results First Posted: January 21, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)