Pregnancy Clinical Trial
Official title:
Repercussion of Maternal Lifestyle on Obstetric and Neonatal Outcomes
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.
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Federal dos Servidores do Estado | Rio de Janeiro | RJ |
Lead Sponsor | Collaborator |
---|---|
Hospital dos Servidores do Estado do Rio de Janeiro | Rio de Janeiro State Research Supporting Foundation (FAPERJ) |
Brazil,
Hoirisch-Clapauch S, Porto MAS. Early neonatal hypoglycemia prediction according to maternal parameters. Thrombosis Research 131(1): S96, 2013.
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 |
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