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

Phase 3

• Conditions: Neonatal Hypoglycemia
• Interventions: Procedure: Blood samples

• Registration Number: NCT02838875
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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 Timeline

• Status Verified: 2016-07
• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-18
• Last Update Submitted: 2016-07-18
• Study First Posted: 2016-07-20
• Last Update Posted: 2016-07-20
• Study Start: 2016-08
• Primary Completion: 2019-08
• Study Completion: 2019-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregnant women at risk population	Blood samples	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 of their affiliation to the at-risk population.

Primary Outcome Measures

Name	Time	Method
Cord blood glucose levels as a predictor to newborns Hypoglycemia	2 weeks	Taking blood samples as a predictor to number of Hypoglycemic children.