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Clinical Trials/NCT02838875
NCT02838875
Unknown
Phase 3

To Examine if the Mother's Glucose Levels and Glucose Levels in the Blood Can Predict Cord Hypoglycemia in Newborns at Risk.

Tel-Aviv Sourasky Medical Center0 sites1,000 target enrollmentAugust 2016

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Neonatal Hypoglycemia
Sponsor
Tel-Aviv Sourasky Medical Center
Enrollment
1000
Primary Endpoint
Cord blood glucose levels as a predictor to newborns Hypoglycemia
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
August 2019
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

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