Effect of DCC on Neonatal Jaundice and Blood Gas Analysis in Infants Born to GDM Mothers
Effect of Delayed Cord Clamping on Neonatal Jaundice and Blood Gas Analysis in Infants Born to Gestational Diabetes Mellitus Mothers
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for not_applicable
Started Sep 2019
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedFirst Submitted
Initial submission to the registry
April 27, 2020
CompletedFirst Posted
Study publicly available on registry
April 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedMarch 23, 2021
March 1, 2021
10 months
April 27, 2020
March 21, 2021
Conditions
Outcome Measures
Primary Outcomes (4)
neonatal cord acid-base status
arterial cord samples were analyzed within 15 min by blood gas analyzer
within the 15 minutes after delivery
neonatal transcutaneous bilirubin level
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
the infants need phototherapy because of high bilirubin level
within the 1 to 3 days of age
Number of infants with neonatal hyperbilirubinemia
the infants need phototherapy because of high bilirubin level
within the 1 to 3 days of age
Secondary Outcomes (1)
neonatal initial blood glucose levels
within the 30 minutes after delivery
Study Arms (2)
delayed cord clamping
EXPERIMENTALclamping the cord at least 30s at birth
early cord clamping
OTHERumbilical cord clamping before 15 seconds
Interventions
umbilical cord clamping more than 30 seconds after birth
umbilical cord clamping within 15 seconds after birth
Eligibility Criteria
You may qualify if:
- Must be a singleton pregnancy
- Clinical diagnosis of gestational diabetes mellitus according to ACOG Practice Bulletin
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027, China
Related Publications (3)
Zhao X, Xu A, Lu X, Chen B, Hua Y, Ma Y. Association of phthalates exposure and sex steroid hormones with late-onset preeclampsia: a case-control study. BMC Pregnancy Childbirth. 2024 Sep 3;24(1):577. doi: 10.1186/s12884-024-06793-5.
PMID: 39227873DERIVEDPan 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.
PMID: 35751710DERIVEDShao 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.
PMID: 35232426DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2020
First Posted
April 30, 2020
Study Start
September 1, 2019
Primary Completion
July 1, 2020
Study Completion
April 1, 2021
Last Updated
March 23, 2021
Record last verified: 2021-03