To Examine if the Mother's Glucose Levels and Glucose Levels in the Blood Can Predict Cord Hypoglycemia in Newborns at Risk.
Trial Snapshot
- Phase
- Phase 3
- Enrollment
- 1,000
- Primary Endpoint
- Cord blood glucose levels as a predictor to newborns Hypoglycemia
Study Overview
Brief Summary
Background Neonatal hypoglycemia is one of the most common metabolic disorders in neonatology. Maintaining stable levels of glucose in the transition from fetal life to life after birth is very important. Yet, except for the recognizing of at-risk populations, there are not many individual measures which can help and predict which newborns (from at-risk populations) will develop hypoglycemia and which will not.
OBJECTIVE our objective is to try to characterize by the mother's glucose levels at birth and by umbilical cord glucose levels who would be at increased risk of hypoglycemia in the hours after birth in the population that is at increased risk of this complication in advance.
Detailed Description
Background Neonatal hypoglycemia is one of the most common metabolic disorders in neonatology. Maintaining stable levels of glucose in the transition from fetal life to life after birth is very important. Yet, except for the recognizing of at-risk populations, there are not many individual measures which can help and predict which newborns (from at-risk populations) will develop hypoglycemia and which will not.
OBJECTIVE our objective is to try to characterize by the mother's glucose levels at birth and by umbilical cord glucose levels who would be at increased risk of hypoglycemia in the hours after birth in the population that is at increased risk of this complication in advance.
PATIENTS & METHODS All women who arrived to the delivery room at Lis hospital and which the newborn is about to undergo glucose levels follow-up after birth regardless the study, because his affiliation to the at-risk population including: delivery below 37th week, maternal diabetes during pregnancy and newborns in weight under percentile 10 or above percentile 90 by Dolberg graphs.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Single pregnancy
- •Vaginal or cesarean birth.
- •Births where there is an indication of neonatal hypoglycemia follow-up - one or more of the following:
- •Delivery week below 37 full weeks.
- •Maternal diabetes during pregnancy (gestational diabetes or pre-gestational).
- •Newborn under percentile 10 by Dolberg graph.
- •Newborn above percentile 90 by Dolberg graph.
Exclusion Criteria
- •Multiple Pregnancy
- •pregnancies in which there is no indication for routine monitoring of glucose levels after birth
Outcomes
Primary Outcomes
Cord blood glucose levels as a predictor to newborns Hypoglycemia
Time Frame: 2 weeks
Taking blood samples as a predictor to number of Hypoglycemic children.
Secondary Outcomes
No secondary outcomes reported