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Clinical Trials/NCT04898868
NCT04898868
Completed
Not Applicable

Investigation on the Effects of Delayed Cord Clamping on Maternal and Neonatal Outcomes: Part I. Association Between Blood Volume, the Interval From Delivery to Cord Clamping, and Number of Umbilical Cord Milking

Chang Gung Memorial Hospital1 site in 1 country80 target enrollmentMay 19, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
Chang Gung Memorial Hospital
Enrollment
80
Locations
1
Primary Endpoint
Blood volume
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Delayed umbilical cord clamping (DCC), usually 1-3 minutes, is reported to be beneficial for term and preterm infants. Nevertheless, there are reasons that urge us to reevaluate the effect of DCC. First, most prior studies were conducted on American and European women. The benefits of DCC in the infants born to Asian women is not clear. Second, neonates born to Asian mothers usually have lower birth weights and placental weights compared to the neonates and placentas of American and European women. The optimal duration of DCC in Asian women remains undetermined. The objective of this study is to determine the association between the blood volume collected and the interval from delivery to cord clamping and number of umbilical cord milking in women with normal term pregnancies with vaginal delivery or elective cesarean delivery (CS). Results form this study will help us determine the optimal duration of DCC or numbers of cord milking in our population in the following studies.

Detailed Description

Delayed umbilical cord clamping (DCC), usually 1-3 minutes, is reported to be beneficial for term and preterm infants. In term infants, DCC increases hemoglobin levels at birth and improves iron stores in the first several months of life, which may have a favorable effect on development outcomes. In preterm infants, the benefits of DCC include improved transitional circulation, better establishment of red blood cell volume, decreased need for blood transfusion, and lower incidence of necrotizing enterocolitis and intraventricular hemorrhage. DCC was not associated with increased risk of postpartum hemorrhage or increased blood loss at delivery, nor was it associated with the need for blood transfusion. Three is a small increase in the incidence of jaundice that requires phototherapy in infants undergoing DCC. Given the benefits of most newborns, a number of professional organizations recommends DCC in term and preterm infants, when feasible. There are reasons that urge us to reevaluate the effect of DCC in our population. First, most prior studies were conducted on American and European women. The benefits of DCC in the infants born to Asian women is not clear. Second, neonates born to Asian mothers usually have lower birth weights and placental weights compared to the neonates and placentas of American and European women. The optimal duration of DCC in Asian women remains undetermined. With the aforementioned reasons, the investigators will conduct a study to clarify the effects of DCC and umbilical cord milking on maternal and neonatal outcomes in Taiwanese women. Our objective is to determine the association between the blood volume collected and the interval from delivery to cord clamping and number of umbilical cord milking in women with normal term pregnancies with vaginal delivery or elective cesarean delivery (CS);.

Registry
clinicaltrials.gov
Start Date
May 19, 2021
End Date
June 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Principal Investigator
Principal Investigator

Tai-Ho Hung

Attending physician, Dept of Obs & Gyn

Chang Gung Memorial Hospital

Eligibility Criteria

Inclusion Criteria

  • Women with a normal singleton term pregnancy (37-41 weeks of gestation) and preparing for vaginal delivery
  • Women with a normal singleton term pregnancy (37-41 weeks of gestation) and preparing for CS for previous CS or fetal malpresentation

Exclusion Criteria

  • Pregnancies complicated by gestational hypertensive disorders, diabetes mellitus, gestational diabetes mellitus, placenta previa, multiple gestation, fetal growth restriction, fetal anomalies (chromosomal or structural), and reassuring fetal heart rate tracing during delivery.
  • Women plan to store her cord blood in a cord blood bank.

Outcomes

Primary Outcomes

Blood volume

Time Frame: delivery of the baby

Total cord blood volume collected with spontaneous drainage or cord milking

Secondary Outcomes

  • Hematocrit difference(Change from admission for delivery to the next day after delivery)
  • Hemoglobin difference(Change from admission for delivery to the next day after delivery)

Study Sites (1)

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