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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
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neonatal Hypoglycemia

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

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

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

    First Posted
    July 18, 2016
    Last Updated
    July 18, 2016
    Sponsor
    Tel-Aviv Sourasky Medical Center
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    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

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