Clinical trial NCT02838875: To Examine if the Mother's Glucose Levels and Glucose Levels in the Blood Can Predict Cord Hypoglycemia in Newborns at Risk.
Official title: To Examine if the Mother's Glucose Levels and Glucose Levels in the Blood Can Predict Cord Hypoglycemia in Newborns at Risk.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Neonatal Hypoglycemia
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-07-20
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

1. Single pregnancy
2. Vaginal or cesarean birth.
3. 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:

1. Multiple Pregnancy
2. pregnancies in which there is no indication for routine monitoring of glucose levels after birth

Primary outcomes:
measure: Cord blood glucose levels as a predictor to newborns Hypoglycemia
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tel Aviv Medical Center
name: Yariv Yogev, professor
role: PRINCIPAL_INVESTIGATOR
References: