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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.

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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02838875
Enrollment
1000
Registered
2016-07-20
Start date
2016-08-31
Completion date
2019-08-31
Last updated
2016-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Hypoglycemia

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.

Interventions

PROCEDUREBlood samples

After birth - taking blood sample from the umbilical cord (arterial and venous) + blood sample from the patient.

Sponsors

Tel-Aviv Sourasky Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Cord blood glucose levels as a predictor to newborns Hypoglycemia2 weeksTaking blood samples as a predictor to number of Hypoglycemic children.

Contacts

Primary ContactYariv Yogev, professor
yarivy@tlvmc.gov.il052-7360616

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026