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

NCT ID: NCT04369313

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2021-04-01

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.

Conditions

Gestational Diabetes Mellitus; Neonatal Hyperbilirubinemia; Neonatal Asphyxia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

delayed cord clamping

clamping the cord at least 30s at birth

Group Type: EXPERIMENTAL

delayed cord clamping

Intervention Type: PROCEDURE

umbilical cord clamping more than 30 seconds after birth

early cord clamping

umbilical cord clamping before 15 seconds

Group Type: OTHER

early cord clamping

Intervention Type: PROCEDURE

umbilical cord clamping within 15 seconds after birth

Interventions

delayed cord clamping

umbilical cord clamping more than 30 seconds after birth

Intervention Type: PROCEDURE

early cord clamping

umbilical cord clamping within 15 seconds after birth

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital of Wenzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

ying hua, doctorate

Role: CONTACT

wzfeyhy1015@126.com

13676403165

yiyu qian, Master

Role: CONTACT

qyy490549439@163.com

15058716761

Facility Contacts

ying hua, Doctor

Role: primary

wzfeyhy1015@126.com

13676403165

References

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.

Reference Type: DERIVED

PMID: 39227873 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35751710 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35232426 (View on PubMed)

Other Identifiers

SAHoWMU-CR2020-07-107

Identifier Type: -

Identifier Source: org_study_id