Clinical trial NCT04898868: Association Between Blood Volume, the Interval From Delivery to Cord Clamping, and Number of Umbilical Cord Milking
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Umbilical Cord Issue
Placental Transfusion
Keywords: Delayed umbilical cord clamping
umbilical cord milking
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will recruit 80 women normal term pregnancy; 40 with vaginal delivery and 40 with elective CS for previous CS or fetal malpresentation.

Participants will be randomized into 4 groups: group 1, vaginal delivery with cord blood spontaneous drainage; group 2, vaginal delivery with cord milking; group 3, CS with cord blood spontaneous drainage; group 4, CS with cord milking. In women allocated to groups of cord blood spontaneous drainage, two clamps will placed at 4 finger breadths from the infant's abdomen and cut between two clamps. The newborns will be taken care by the nurse after delivery. The clamp on the placenta site will be removed and record the drainage time and amount of cord blood to a measuring glass. In women allocated to groups of cord milking group, the umbilical cord will be squeezed several times, 5 seconds between each squeezing, to collect cord blood after delivery. The number of cord milking and the volume of blood collected will be recorded.
Primary purpose: HEALTH_SERVICES_RESEARCH

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);.

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.

Primary outcomes:
measure: Blood volume
timeFrame: delivery of the baby
Secondary outcomes:
measure: Hemoglobin difference
timeFrame: Change from admission for delivery to the next day after delivery
measure: Hematocrit difference
timeFrame: Change from admission for delivery to the next day after delivery
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Tai-Ho Hung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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