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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369313
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital of Wenzhou Medical University

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.


Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Neonatal Hyperbilirubinemia Neonatal Asphyxia Procedure: delayed cord clamping Procedure: early cord clamping Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Delayed Cord Clamping on Neonatal Jaundice and Blood Gas Analysis in Infants Born to Gestational Diabetes Mellitus Mothers
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

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

early cord clamping
umbilical cord clamping before 15 seconds
Procedure: early cord clamping
umbilical cord clamping within 15 seconds after birth




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369313


Contacts
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Contact: ying hua, doctorate 13676403165 wzfeyhy1015@126.com
Contact: yiyu qian, Master 15058716761 qyy490549439@163.com

Locations
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China, Zhejiang
department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325027
Contact: ying hua, Doctor    13676403165    wzfeyhy1015@126.com   
Sponsors and Collaborators
Second Affiliated Hospital of Wenzhou Medical University
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Responsible Party: Second Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT04369313    
Other Study ID Numbers: SAHoWMU-CR2020-07-107
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Hyperbilirubinemia, Neonatal
Jaundice, Neonatal
Asphyxia Neonatorum
Diabetes Mellitus
Jaundice
Hyperbilirubinemia
Asphyxia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Pathologic Processes
Skin Manifestations
Death
Wounds and Injuries
Infant, Newborn, Diseases