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

Neonatal Hypoglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02838875
• Other study ID #: 0253-16-TLV
• Status: Not yet recruiting
• Phase: Phase 3
• First received: July 18, 2016
• Last updated: July 18, 2016
• Start date: August 2016
• Est. completion date: August 2019

Study information

• Verified date: July 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Yariv Yogev, professor
• Phone: 052-7360616
• Email: yarivy[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hypoglycemia
• Neonatal Hypoglycemia

Intervention

Procedure:
• Blood samples
After birth - taking blood sample from the umbilical cord (arterial and venous) + blood sample from the patient.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cord blood glucose levels as a predictor to newborns Hypoglycemia	Taking blood samples as a predictor to number of Hypoglycemic children.	2 weeks	No