Ignite Creation Date:
2024-05-06 @ 4:09 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04898868
Status:
COMPLETED
Last Update Posted:
2021-07-07
First Post:
2021-05-19
Brief Title:
Association Between Blood Volume the Interval From Delivery to Cord Clamping and Number of Umbilical Cord Milking
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None