Effect of DCC on Neonatal Jaundice and Blood Gas Analysis in Infants Born to GDM Mothers

March 21, 2021 updated by: Second Affiliated Hospital of Wenzhou Medical University

Effect of Delayed Cord Clamping on Neonatal Jaundice and Blood Gas Analysis in Infants Born to Gestational Diabetes Mellitus Mothers

Evidence for benefited newborns following delayed cord clamping (DCC), including increasing hemoglobin and hematocrit levels, improving iron stores, and decreasing need for blood transfusion and incidence of intraventricular hemorrhage, in term or preterm infants led the American College of Obstetricians and Gynecologists (ACOG) to recommend a delayed cord clamping at least 30-60 seconds in vigorous term and preterm infants at birth. Although DCC has been found to be beneficial to infants, the additional blood provided by DCC could increase the incidence of jaundice that requires phototherapy and the hyperbilirubinemia, and the time prolonged by DCC might jeopardize timely resuscitation efforts, if needed. The acid-base status in umbilical cord blood at birth reflects the newborn's aerobic and anaerobic intrauterine metabolisms and is an objective measure of the fetal exposure and response to hypoxia during labour.

Gestational diabetes mellitus (GDM) is a condition in which glucose intolerance develops during pregnancy. It has been estimated in 2009 that nearly 7% of pregnancies are complicated by diabetes and approximately 86% of these cases represented women with GDM. The Hyperglycemia and Adverse Pregnancy Outcome study (HAPO) revealed that the infants of diabetic mothers (IDMs) are at increased risk of neonatal hypoglycemia, hyperbilirubinemia, shoulder dystocia, and birth trauma. And newborns to diabetic mothers are at increased risk of neonatal respiratory distress syndrome (RDS) and hypoxia, a major cause of admission in neonatal intensive care units. There is little direct evidence on the implementation of delayed umbilical cord clamping in the risk group of IDMs. Therefore, it no clear that the effectiveness and impairment of DCC in IDMs.

Therefore, the investigators conducted a prospective study in performing DCC in the infants of diabetic mothers versus the newborns with early cord clamping (ECC) to assess the effect of DCC on neonatal bilirubin levels, hyperbilirubinemia incidence, acid-base status and hypoxia in IDMs.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Recruiting
        • department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

People in the study should meet the following inclusion criteria:

  • Must be a singleton pregnancy
  • Clinical diagnosis of gestational diabetes mellitus according to ACOG Practice Bulletin

Exclusion Criteria:

  • Pregnant women and neonates were excluded if they met the exclusion criteria (not included in if meeting one of following items )
  • Maternal clinical diseases (hypertension disorders, abnormal liver function, Rhesus negative blood group or other blood system disease)
  • Maternal other pregnancy complications (polyhydramnios, oligohydramnios, placenta praevia, and abruptio placentae).
  • Delivery before 37 weeks or after 42 weeks
  • Neonatal weight was < 2.5 kg or>4.0 kg
  • Neonates had major congenital malformations (congenital anal atresia, congenital biliary atresia, congenital heart disease and so on, whether prenatal suspicion or diagnosis postpartum)
  • Neonatal septicemia, hemolytic disease or other diseases affecting bilirubin metabolism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: delayed cord clamping
clamping the cord at least 30s at birth
Procedure: delayed cord clamping
umbilical cord clamping more than 30 seconds after birth
Other: early cord clamping
umbilical cord clamping before 15 seconds
Procedure: early cord clamping
umbilical cord clamping within 15 seconds after birth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neonatal cord acid-base status
Time Frame: within the 15 minutes after delivery
arterial cord samples were analyzed within 15 min by blood gas analyzer
within the 15 minutes after delivery
neonatal transcutaneous bilirubin level
Time Frame: within the 1 to 3 days of age
The transcutaneous bilirubin was measured by the uniform TcB device three times a day
within the 1 to 3 days of age
Number of infants with neonatal jaundice requiring phototherapy
Time Frame: within the 1 to 3 days of age
the infants need phototherapy because of high bilirubin level
within the 1 to 3 days of age
Number of infants with neonatal hyperbilirubinemia
Time Frame: within the 1 to 3 days of age
the infants need phototherapy because of high bilirubin level
within the 1 to 3 days of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neonatal initial blood glucose levels
Time Frame: within the 30 minutes after delivery
The initial blood glucose levels were measured within 30 minutes after birth and before breastfeeding
within the 30 minutes after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Wenzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

July 1, 2020

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

April 29, 2020

First Posted (Actual)

April 30, 2020

Study Record Updates

Last Update Posted (Actual)

March 23, 2021

Last Update Submitted That Met QC Criteria

March 21, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAHoWMU-CR2020-07-107

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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