Maternal Lifestyle and Neonatal Hypoglycemia
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|ClinicalTrials.gov Identifier: NCT01409382|
Recruitment Status : Completed
First Posted : August 4, 2011
Results First Posted : January 21, 2016
Last Update Posted : September 29, 2016
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|
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|
|Intervention Model:||Parallel Assignment|
|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|
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.
- 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.
- Refractory Hypoglycemia [ Time Frame: One hour after feeding or after intravenous dextrose ]
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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT01409382
|Hospital Federal dos Servidores do Estado|
|Rio de Janeiro, RJ, Brazil, 20221-903|
|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|