Status:

COMPLETED

Maternal Lifestyle and Neonatal Hypoglycemia

Lead Sponsor:

Hospital dos Servidores do Estado do Rio de Janeiro

Collaborating Sponsors:

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Conditions:

Hyperinsulinemia

Miscarriages

Eligibility:

All Genders

Up to 40 years

Phase:

NA

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 a...

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. Mother...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    March 1 2011

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2015

    Estimated Enrollment :

    480 Patients enrolled

    Trial Details

    Trial ID

    NCT01409382

    Start Date

    March 1 2011

    End Date

    October 1 2015

    Last Update

    September 29 2016

    Active Locations (1)

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    Hospital Federal dos Servidores do Estado

    Rio de Janeiro, Rio de Janeiro, Brazil, 20221-903