Maternal Lifestyle and Neonatal Hypoglycemia
Primary Purpose
Hyperinsulinemia, Miscarriages, Pregnancy
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Daily brisk walking plus a carbohydrate-restricted diet
Sponsored by
About this trial
This is an interventional prevention trial for Hyperinsulinemia focused on measuring neonatal hypoglycemia, pregnancy, physical activity, sedentary lifestyle, high-glycemic index diet, take-home baby, recurrent miscarriages, preterm delivery
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.
Sites / Locations
- Hospital Federal dos Servidores do Estado
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Lifestyle counseling
Standard follow-up
Arm Description
Daily brisk walking plus a carbohydrate-restricted diet
Prenatal care will proceed according to the routine.
Outcomes
Primary Outcome Measures
Neonatal Hypoglycemia
Any glucose level equal or below 40mg/dL at 1, 2 or 4 h after birth, obtained by heelstick.
Secondary Outcome Measures
Refractory Hypoglycemia
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.
Full Information
NCT ID
NCT01409382
First Posted
May 27, 2011
Last Updated
August 19, 2016
Sponsor
Hospital dos Servidores do Estado do Rio de Janeiro
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
1. Study Identification
Unique Protocol Identification Number
NCT01409382
Brief Title
Maternal Lifestyle and Neonatal Hypoglycemia
Official Title
Repercussion of Maternal Lifestyle on Obstetric and Neonatal Outcomes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital dos Servidores do Estado do Rio de Janeiro
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
480 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle counseling
Arm Type
Active Comparator
Arm Description
Daily brisk walking plus a carbohydrate-restricted diet
Arm Title
Standard follow-up
Arm Type
No Intervention
Arm Description
Prenatal care will proceed according to the routine.
Intervention Type
Behavioral
Intervention Name(s)
Daily brisk walking plus a carbohydrate-restricted diet
Intervention Description
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 Outcome Measure Information:
Title
Neonatal Hypoglycemia
Description
Any glucose level equal or below 40mg/dL at 1, 2 or 4 h after birth, obtained by heelstick.
Time Frame
1, 2 and 4 h after birth.
Secondary Outcome Measure Information:
Title
Refractory Hypoglycemia
Description
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.
Time Frame
One hour after feeding or after intravenous dextrose
Other Pre-specified Outcome Measures:
Title
Pregnancy and Neonatal Outcomes
Description
Early miscarriages, 2nd and 3rd trimester losses, preterm deliveries, take-home babies, neonatal hypoglycemia: number of babies
Time Frame
Three years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria A Sayeg-Porto, MD, PhD
Organizational Affiliation
Hospital dos Servidores do Estado, RJ; Universidade Federal do Rio de Janeiro
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paulo R Benchimol-Barbosa, MD, DSc
Organizational Affiliation
Universidade Gama Filho; COPPE/UFRJ
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Silvia Hoirisch-Clapauch, MD
Organizational Affiliation
Hospital dos Servidores do Estado, RJ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Federal dos Servidores do Estado
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20221-903
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
Citation
Hoirisch-Clapauch S, Porto MAS. Early neonatal hypoglycemia prediction according to maternal parameters. Thrombosis Research 131(1): S96, 2013.
Results Reference
result
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Maternal Lifestyle and Neonatal Hypoglycemia
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