Effect of DCC on Neonatal Jaundice and Blood Gas Analysis in Infants Born to GDM Mothers
Primary Purpose
Gestational Diabetes Mellitus, Neonatal Hyperbilirubinemia, Neonatal Asphyxia
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
delayed cord clamping
early cord clamping
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes Mellitus
Eligibility Criteria
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.
Sites / Locations
- department of obstetrics of Second Affiliated Hospital of Wenzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
delayed cord clamping
early cord clamping
Arm Description
clamping the cord at least 30s at birth
umbilical cord clamping before 15 seconds
Outcomes
Primary Outcome Measures
neonatal cord acid-base status
arterial cord samples were analyzed within 15 min by blood gas analyzer
neonatal transcutaneous bilirubin level
The transcutaneous bilirubin was measured by the uniform TcB device three times a day
Number of infants with neonatal jaundice requiring phototherapy
the infants need phototherapy because of high bilirubin level
Number of infants with neonatal hyperbilirubinemia
the infants need phototherapy because of high bilirubin level
Secondary Outcome Measures
neonatal initial blood glucose levels
The initial blood glucose levels were measured within 30 minutes after birth and before breastfeeding
Full Information
NCT ID
NCT04369313
First Posted
April 27, 2020
Last Updated
March 21, 2021
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04369313
Brief Title
Effect of DCC on Neonatal Jaundice and Blood Gas Analysis in Infants Born to GDM Mothers
Official Title
Effect of Delayed Cord Clamping on Neonatal Jaundice and Blood Gas Analysis in Infants Born to Gestational Diabetes Mellitus Mothers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
April 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Wenzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus, Neonatal Hyperbilirubinemia, Neonatal Asphyxia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
delayed cord clamping
Arm Type
Experimental
Arm Description
clamping the cord at least 30s at birth
Arm Title
early cord clamping
Arm Type
Other
Arm Description
umbilical cord clamping before 15 seconds
Intervention Type
Procedure
Intervention Name(s)
delayed cord clamping
Intervention Description
umbilical cord clamping more than 30 seconds after birth
Intervention Type
Procedure
Intervention Name(s)
early cord clamping
Intervention Description
umbilical cord clamping within 15 seconds after birth
Primary Outcome Measure Information:
Title
neonatal cord acid-base status
Description
arterial cord samples were analyzed within 15 min by blood gas analyzer
Time Frame
within the 15 minutes after delivery
Title
neonatal transcutaneous bilirubin level
Description
The transcutaneous bilirubin was measured by the uniform TcB device three times a day
Time Frame
within the 1 to 3 days of age
Title
Number of infants with neonatal jaundice requiring phototherapy
Description
the infants need phototherapy because of high bilirubin level
Time Frame
within the 1 to 3 days of age
Title
Number of infants with neonatal hyperbilirubinemia
Description
the infants need phototherapy because of high bilirubin level
Time Frame
within the 1 to 3 days of age
Secondary Outcome Measure Information:
Title
neonatal initial blood glucose levels
Description
The initial blood glucose levels were measured within 30 minutes after birth and before breastfeeding
Time Frame
within the 30 minutes after delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ying hua, doctorate
Phone
13676403165
Email
wzfeyhy1015@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
yiyu qian, Master
Phone
15058716761
Email
qyy490549439@163.com
Facility Information:
Facility Name
department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ying hua, Doctor
Phone
13676403165
Email
wzfeyhy1015@126.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
35751710
Citation
Pan S, Lu Q, Lan Y, Peng L, Yu X, Hua Y. Differential effects of delayed cord clamping on bilirubin levels in normal and diabetic pregnancies. Eur J Pediatr. 2022 Aug;181(8):3111-3117. doi: 10.1007/s00431-022-04536-2. Epub 2022 Jun 25.
Results Reference
derived
PubMed Identifier
35232426
Citation
Shao H, Lan Y, Qian Y, Chen R, Peng L, Hua Y, Wang X. Effect of later cord clamping on umbilical cord blood gas in term neonates of diabetic mothers: a randomized clinical trial. BMC Pediatr. 2022 Mar 1;22(1):111. doi: 10.1186/s12887-022-03170-z.
Results Reference
derived
Learn more about this trial
Effect of DCC on Neonatal Jaundice and Blood Gas Analysis in Infants Born to GDM Mothers
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