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

NCT02838875 | Unknown Phase 3 DMC

• 1 other identifier: 0253-16-TLV
• Study Type: interventional
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neonatal Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Cord blood glucose levels as a predictor to newborns Hypoglycemia

  Taking blood samples as a predictor to number of Hypoglycemic children.

  2 weeks

Study Arms (1)

Pregnant women at risk population

EXPERIMENTAL

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.

Procedure: Blood samples

Interventions

Blood samples PROCEDURE

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

Pregnant women at risk population

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Multiple Pregnancy
• pregnancies in which there is no indication for routine monitoring of glucose levels after birth

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Yariv Yogev, professor

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yariv Yogev, professor

CONTACT

052-7360616; yarivy@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2016
• First Posted: July 20, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: July 20, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share