Maternal Lifestyle and Neonatal Hypoglycemia

Pregnancy Clinical Trial

Official title:

Repercussion of Maternal Lifestyle on Obstetric and Neonatal Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409382
• Other study ID #: 000416-09-08-2010
• Status: Completed
• Phase: N/A
• First received: May 27, 2011
• Last updated: December 13, 2015
• Start date: March 2011
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Hospital dos Servidores do Estado do Rio de Janeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: October 2015
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Hyperinsulinemia
• Hyperinsulinism
• Hypoglycemia
• Miscarriages
• Pregnancy
• Sedentary Lifestyle

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Federal dos Servidores do Estado	Rio de Janeiro	RJ

Sponsors (2)

Lead Sponsor	Collaborator
Hospital dos Servidores do Estado do Rio de Janeiro	Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pregnancy and Neonatal Outcomes	Early miscarriages, 2nd and 3rd trimester losses, preterm deliveries, take-home babies, neonatal hypoglycemia: number of babies	Three years	No
Primary	Neonatal Hypoglycemia	Any glucose level equal or below 40mg/dL at 1, 2 or 4 h after birth, obtained by heelstick.	1, 2 and 4 h after birth.	No
Secondary	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.	One hour after feeding or after intravenous dextrose	No

External Links

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