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

July 3, 2021 updated by: Tai-Ho Hung, Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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);.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10507
        • Taipei Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: vaginal delivery with cord blood spontaneous drainage
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.
Procedure: cord blood spontaneous drainage
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 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 recored.
Experimental: vaginal delivery with cord milking
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.
Procedure: Umbilical cord miking
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 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.
Experimental: CS with cord blood spontaneous drainage
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.
Procedure: cord blood spontaneous drainage
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 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 recored.
Experimental: CS with cord milking
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.
Procedure: Umbilical cord miking
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood volume
Time Frame: delivery of the baby
Total cord blood volume collected with spontaneous drainage or cord milking
delivery of the baby

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin difference
Time Frame: Change from admission for delivery to the next day after delivery
The difference of maternal hemoglobin level before and after delivery
Change from admission for delivery to the next day after delivery
Hematocrit difference
Time Frame: Change from admission for delivery to the next day after delivery
The difference of maternal hematocrit level before and after delivery
Change from admission for delivery to the next day after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Tai-Ho Hung, MD, PhD, Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2021

Primary Completion (Actual)

June 23, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 3, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201901045A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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