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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| delayed cord clamping | Experimental | clamping the cord at least 30s at birth |
|
| early cord clamping | Other | umbilical cord clamping before 15 seconds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| delayed cord clamping | Procedure | umbilical cord clamping more than 30 seconds after birth |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| neonatal initial blood glucose levels | The initial blood glucose levels were measured within 30 minutes after birth and before breastfeeding | within the 30 minutes after delivery |
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Inclusion Criteria:
People in the study should meet the following inclusion criteria:
Exclusion Criteria:
female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ying hua, doctorate | Contact | 13676403165 | wzfeyhy1015@126.com | |
| yiyu qian, Master | Contact | 15058716761 | qyy490549439@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| department of obstetrics of Second Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325027 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39227873 | Derived | 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. | |
| 35751710 | Derived | 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. |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D051556 | Hyperbilirubinemia, Neonatal |
| D001238 | Asphyxia Neonatorum |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D000087526 | Umbilical Cord Clamping |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| early cord clamping | Procedure | umbilical cord clamping within 15 seconds after birth |
|
| 35232426 | Derived | 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. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |