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

NCT ID: NCT02838875

Last Updated: 2016-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-08-31

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.

Conditions

Neonatal Hypoglycemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Pregnant women at risk population

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.

Group Type: EXPERIMENTAL

Blood samples

Intervention Type: PROCEDURE

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

Interventions

Blood samples

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yariv Yogev, professor

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Central Contacts

Yariv Yogev, professor

Role: CONTACT

yarivy@tlvmc.gov.il

052-7360616

Other Identifiers

0253-16-TLV

Identifier Type: -

Identifier Source: org_study_id