Maternal Lifestyle and Neonatal Hypoglycemia

This study has been completed.
Sponsor:
Collaborator:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by (Responsible Party):
Silvia Hoirisch Clapauch, Hospital dos Servidores do Estado do Rio de Janeiro
ClinicalTrials.gov Identifier:
NCT01409382
First received: May 27, 2011
Last updated: July 31, 2016
Last verified: July 2016
  Purpose

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.


Condition Intervention
Hyperinsulinemia
Miscarriages
Pregnancy
Sedentary Lifestyle
Hypoglycemia
Behavioral: Daily brisk walking plus a carbohydrate-restricted diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Repercussion of Maternal Lifestyle on Obstetric and Neonatal Outcomes

Resource links provided by NLM:


Further study details as provided by Hospital dos Servidores do Estado do Rio de Janeiro:

Primary Outcome Measures:
  • Neonatal Hypoglycemia [ Time Frame: 1, 2 and 4 h after birth. ] [ Designated as safety issue: No ]
    Any glucose level equal or below 40mg/dL at 1, 2 or 4 h after birth, obtained by heelstick.


Secondary Outcome Measures:
  • Refractory Hypoglycemia [ Time Frame: One hour after feeding or after intravenous dextrose ] [ Designated as safety issue: No ]

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

    1. 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.
    2. A new heel stick blood sample will be drawn to assess glucose levels.
    3. Neonates with persistent hypoglycemia will be considered as refractory hypoglycemia.


Other Outcome Measures:
  • Pregnancy and Neonatal Outcomes [ Time Frame: Three years ] [ Designated as safety issue: No ]
    Early miscarriages, 2nd and 3rd trimester losses, preterm deliveries, take-home babies, neonatal hypoglycemia: number of babies


Enrollment: 480
Study Start Date: March 2011
Study Completion Date: October 2015
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lifestyle counseling
Daily brisk walking plus a carbohydrate-restricted diet
Behavioral: Daily brisk walking plus a carbohydrate-restricted diet
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.
No Intervention: Standard follow-up
Prenatal care will proceed according to the routine.

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

Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01409382

Locations
Brazil
Hospital Federal dos Servidores do Estado
Rio de Janeiro, RJ, Brazil, 20221-903
Sponsors and Collaborators
Hospital dos Servidores do Estado do Rio de Janeiro
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Investigators
Principal Investigator: 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
  More Information

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

Responsible Party: Silvia Hoirisch Clapauch, Principal investigator, Hospital dos Servidores do Estado do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT01409382     History of Changes
Other Study ID Numbers: 000416-09-08-2010 
Study First Received: May 27, 2011
Results First Received: April 26, 2013
Last Updated: July 31, 2016
Health Authority: Brazil: Ethics Committee
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by Hospital dos Servidores do Estado do Rio de Janeiro:
neonatal hypoglycemia
pregnancy
physical activity
sedentary lifestyle
high-glycemic index diet
take-home baby
recurrent miscarriages
preterm delivery

Additional relevant MeSH terms:
Hypoglycemia
Abortion, Spontaneous
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on August 25, 2016