Maternal Lifestyle and Neonatal Hypoglycemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01409382
Recruitment Status : Completed
First Posted : August 4, 2011
Results First Posted : January 21, 2016
Last Update Posted : September 29, 2016
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

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia

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.

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

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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01409382

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)
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

Additional Information:
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 Identifier: NCT01409382     History of Changes
Other Study ID Numbers: 000416-09-08-2010
First Posted: August 4, 2011    Key Record Dates
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
physical activity
sedentary lifestyle
high-glycemic index diet
take-home baby
recurrent miscarriages
preterm delivery

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