Maternal Lifestyle and Neonatal Hypoglycemia

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Hyperinsulinemia; Miscarriages; Pregnancy; Sedentary Lifestyle; Hypoglycemia	Behavioral: Daily brisk walking plus a carbohydrate-restricted diet	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	480 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Prevention
Official Title:	Repercussion of Maternal Lifestyle on Obstetric and Neonatal Outcomes
Study Start Date :	March 2011
Actual Primary Completion Date :	April 2013
Actual Study Completion Date :	October 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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.

Outcome Measures

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Primary Outcome Measures :

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 Outcome Measures :

1. Refractory Hypoglycemia [ Time Frame: One hour after feeding or after intravenous dextrose ]

   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:

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

Eligibility Criteria

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Ages Eligible for Study:	up to 40 Years (Child, Adult)
Sexes Eligible for Study:	All
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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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

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

Publications of Results:

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
First Posted:	August 4, 2011
Results First Posted:	January 21, 2016
Last Update Posted:	September 29, 2016
Last Verified:	August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes

Keywords provided by Silvia Hoirisch Clapauch, 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