To Examine if the Mother's Glucose Levels and Glucose Levels in the Blood Can Predict Cord Hypoglycemia in Newborns at Risk.
Primary Purpose
Neonatal Hypoglycemia
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Blood samples
Sponsored by
About this trial
This is an interventional diagnostic trial for Neonatal Hypoglycemia
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pregnant women at risk population
Arm Description
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.
Outcomes
Primary Outcome Measures
Cord blood glucose levels as a predictor to newborns Hypoglycemia
Taking blood samples as a predictor to number of Hypoglycemic children.
Secondary Outcome Measures
Full Information
NCT ID
NCT02838875
First Posted
July 18, 2016
Last Updated
July 18, 2016
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02838875
Brief Title
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
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Hypoglycemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pregnant women at risk population
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Blood samples
Intervention Description
After birth - taking blood sample from the umbilical cord (arterial and venous) + blood sample from the patient.
Primary Outcome Measure Information:
Title
Cord blood glucose levels as a predictor to newborns Hypoglycemia
Description
Taking blood samples as a predictor to number of Hypoglycemic children.
Time Frame
2 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yariv Yogev, professor
Phone
052-7360616
Email
yarivy@tlvmc.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yariv Yogev, professor
Organizational Affiliation
Tel Aviv Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Examine if the Mother's Glucose Levels and Glucose Levels in the Blood Can Predict Cord Hypoglycemia in Newborns at Risk.
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