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

NCT04898868 | Completed

• 1 other identifier: 201901045A3
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Umbilical Cord Issue; Placental Transfusion

Keywords

Delayed umbilical cord clamping; umbilical cord milking

Outcome Measures

Primary Outcomes (1)

• Blood volume

  Total cord blood volume collected with spontaneous drainage or cord milking

  delivery of the baby

Secondary Outcomes (2)

• Hemoglobin difference

  Change from admission for delivery to the next day after delivery

• Hematocrit difference

  Change from admission for delivery to the next day after delivery

Study Arms (4)

vaginal delivery with cord blood spontaneous drainage

EXPERIMENTAL

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

vaginal delivery with cord milking

EXPERIMENTAL

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

CS with cord blood spontaneous drainage

EXPERIMENTAL

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

CS with cord milking

EXPERIMENTAL

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

Interventions

cord blood spontaneous drainage PROCEDURE

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.

CS with cord blood spontaneous drainage; vaginal delivery with cord blood spontaneous drainage

Umbilical cord miking PROCEDURE

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.

CS with cord milking; vaginal delivery with cord milking

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Taipei Chang Gung Memorial Hospital

Taipei, 10507, Taiwan

Location

Related Publications (10)

• Kugelman A, Borenstein-Levin L, Riskin A, Chistyakov I, Ohel G, Gonen R, Bader D. Immediate versus delayed umbilical cord clamping in premature neonates born < 35 weeks: a prospective, randomized, controlled study. Am J Perinatol. 2007 May;24(5):307-15. doi: 10.1055/s-2007-981434. Epub 2007 May 21.

  PMID: 17516307 BACKGROUND

• Takami T, Suganami Y, Sunohara D, Kondo A, Mizukaki N, Fujioka T, Hoshika A, Akutagawa O, Isaka K. Umbilical cord milking stabilizes cerebral oxygenation and perfusion in infants born before 29 weeks of gestation. J Pediatr. 2012 Oct;161(4):742-7. doi: 10.1016/j.jpeds.2012.03.053. Epub 2012 May 12.

  PMID: 22578578 BACKGROUND

• Rabe H, Reynolds G, Diaz-Rossello J. Early versus delayed umbilical cord clamping in preterm infants. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD003248. doi: 10.1002/14651858.CD003248.pub2.

  PMID: 15495045 BACKGROUND

• McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.

  PMID: 23843134 BACKGROUND

• Fogarty M, Osborn DA, Askie L, Seidler AL, Hunter K, Lui K, Simes J, Tarnow-Mordi W. Delayed vs early umbilical cord clamping for preterm infants: a systematic review and meta-analysis. Am J Obstet Gynecol. 2018 Jan;218(1):1-18. doi: 10.1016/j.ajog.2017.10.231. Epub 2017 Oct 30.

  PMID: 29097178 BACKGROUND

• Tarnow-Mordi W, Morris J, Kirby A, Robledo K, Askie L, Brown R, Evans N, Finlayson S, Fogarty M, Gebski V, Ghadge A, Hague W, Isaacs D, Jeffery M, Keech A, Kluckow M, Popat H, Sebastian L, Aagaard K, Belfort M, Pammi M, Abdel-Latif M, Reynolds G, Ariff S, Sheikh L, Chen Y, Colditz P, Liley H, Pritchard M, de Luca D, de Waal K, Forder P, Duley L, El-Naggar W, Gill A, Newnham J, Simmer K, Groom K, Weston P, Gullam J, Patel H, Koh G, Lui K, Marlow N, Morris S, Sehgal A, Wallace E, Soll R, Young L, Sweet D, Walker S, Watkins A, Wright I, Osborn D, Simes J; Australian Placental Transfusion Study Collaborative Group. Delayed versus Immediate Cord Clamping in Preterm Infants. N Engl J Med. 2017 Dec 21;377(25):2445-2455. doi: 10.1056/NEJMoa1711281. Epub 2017 Oct 29.

  PMID: 29081267 BACKGROUND

• Kaempf JW, Tomlinson MW, Kaempf AJ, Wu Y, Wang L, Tipping N, Grunkemeier G. Delayed umbilical cord clamping in premature neonates. Obstet Gynecol. 2012 Aug;120(2 Pt 1):325-30. doi: 10.1097/AOG.0b013e31825f269f.

  PMID: 22825092 BACKGROUND

• Committee Opinion No. 684: Delayed Umbilical Cord Clamping After Birth. Obstet Gynecol. 2017 Jan;129(1):1. doi: 10.1097/AOG.0000000000001860.

  PMID: 28002310 BACKGROUND

• Perry IJ, Beevers DG, Whincup PH, Bareford D. Predictors of ratio of placental weight to fetal weight in multiethnic community. BMJ. 1995 Feb 18;310(6977):436-9. doi: 10.1136/bmj.310.6977.436.

  PMID: 7873949 BACKGROUND

• Jones J, Stevens CE, Rubinstein P, Robertazzi RR, Kerr A, Cabbad MF. Obstetric predictors of placental/umbilical cord blood volume for transplantation. Am J Obstet Gynecol. 2003 Feb;188(2):503-9. doi: 10.1067/mob.2003.19.

  PMID: 12592263 BACKGROUND

MeSH Terms

Conditions

Fetofetal Transfusion

Condition Hierarchy (Ancestors)

Anemia, Neonatal; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Tai-Ho Hung, MD, PhD

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician, Dept of Obs & Gyn

Model Details: 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.

Study Record Dates

• First Submitted: May 19, 2021
• First Posted: May 24, 2021
• Study Start: May 19, 2021
• Primary Completion: June 23, 2021
• Study Completion: June 30, 2021
• Last Updated: July 7, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)