Association Between Blood Volume, the Interval From Delivery to Cord Clamping, and Number of Umbilical Cord Milking

Chang Gung Medical Foundation

Status: Completed

Conditions: Umbilical Cord Issue; Pregnancy Related; Placental Transfusion

Treatments: Procedure: Umbilical cord miking; Procedure: cord blood spontaneous drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT04898868

201901045A3

Details and patient eligibility

About

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.

Full 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);.

Enrollment: 80 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

vaginal delivery with cord blood spontaneous drainage

Experimental group

Description:

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 immediately after delivery of the baby. The clamp on the placental site will be removed and the drainage time and amount of cord blood to a measuring glass will be recorded.

Treatment:

Procedure: cord blood spontaneous drainage

vaginal delivery with cord milking

Experimental group

Description:

In women allocated to groups of cord milking group, two clamps will placed at 4 finger breadths from the newborn's abdomen and cut between two clamps immediately after delivery of the baby. The newborns will be taken care by the nurse. The clamp on the placental site will be removed, then the umbilical cord will be squeezed several times, 5 seconds between each squeezing, to collect cord blood in a measuring glass. The number of cord milking and the volume of blood collected will be recorded.

Treatment:

Procedure: Umbilical cord miking

CS with cord blood spontaneous drainage

Experimental group

Description:

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 immediately after delivery of the baby. The clamp on the placental site will be removed and the drainage time and amount of cord blood to a measuring glass will be recorded.

Treatment:

Procedure: cord blood spontaneous drainage

CS with cord milking

Experimental group

Description:

In women allocated to groups of cord milking group, two clamps will placed at 4 finger breadths from the newborn's abdomen and cut between two clamps immediately after delivery of the baby. The newborns will be taken care by the nurse. The clamp on the placental site will be removed, then the umbilical cord will be squeezed several times, 5 seconds between each squeezing, to collect cord blood in a measuring glass. The number of cord milking and the volume of blood collected will be recorded.

Treatment:

Procedure: Umbilical cord miking