Effect of Umbilical Cord Milking on Iron Related Health Outcomes for Cesarean-Delivered Infants

NCT02892461 | Completed DMC

• 1 other identifier: 81571517
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to determine whether umbilical cord milking can improve iron related health outcomes for cesarean-delivered infants. Half of participants will receive umbilical cord milking, while the other half will receive routine clinical treatment and care.

Conditions

Anemia, Iron-Deficiency

Keywords

Anemia, Iron-Deficiency; Cesarean Section; Umbilical Cord Milking; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change in infant's serum ferritin (μg/L)

  At birth (baseline)-2 ml umbilical cord blood, 6 and 12 months old-2 ml infant's venous blood for each measure.

  At birth (baseline), 6 and 12 months after birth

Secondary Outcomes (10)

• Change in infant's erythrocyte counts (10^12/L)

  At birth (baseline), 1, 6 and 12 months after birth

• Change in infant's hemoglobin concentration (g/L)

  At birth (baseline), 1, 6 and 12 months after birth

• Change in infant's hematocrit (%)

  At birth (baseline), 1, 6 and 12 months after birth

• Change in infant's weight (kg)

  At birth (baseline), 1, 6, 12 and 18 months after birth

• Change in infant's height (cm)

  At birth (baseline), 1, 6, 12 and 18 months after birth

Study Arms (2)

Umbilical cord milking

EXPERIMENTAL

The cord will be cut at 25 cm from the umbilical stump within 30 seconds after the infant is taken out from the uterus and its blood will be milked to the infant gently and thoroughly in 30 seconds during resuscitation on the radiant warmer, and then the cord will be cut at 2 to 3 cm from the umbilical stump.

Procedure: Umbilical cord milking

Routine clinical treatment and care

NO INTERVENTION

The cord will be dealt with routine clinical method, which means it will be cut twice within 1minute after the infant is taken out from the uterus, the first cut is on the operating table, while the second cut is on the radiant warmer.

Interventions

Umbilical cord milking PROCEDURE

As same as that in arm descriptions.

Umbilical cord milking

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnancy
• Full-term pregnancy (no less than 37 gestational weeks)
• Cesarean section before the labor starts or cesarean section after the labor starts but with cervix less than 3 cm
• Plan to take vaccines and receive routine child health care in the hospital where she gives birth

You may not qualify if:

• Maternal hypertensive disorder
• Gestational diabetes with macrosomia
• Gestational diabetes with polyhydramnios
• Maternal severe anemia with hemoglobin less than 70 g/L
• Maternal coagulation disorders
• Fetal growth restriction
• Major congenital anomalies
• Hemolytic disease of the newborn or hydrops fetalis
• Short umbilical cord length (\< 30 cm)
• Severe cord or placenta abnormalities such as cord prolapse, true knots, placental abruption and placenta previa
• Other conditions that are not suitable for the study judged by the doctors

Sponsors & Collaborators

• Peking University: lead
• National Natural Science Foundation of China: collaborator
• Hunan Provincial Maternal and Child Health Care Hospital: collaborator
• Liuyang Maternal and Child Health Care Hospital: collaborator

Study Sites (2)

Hunan Provincial Maternal and Child Health Care Hospital

Changsha, Hunan, 410008, China

Location

Liuyang Maternal and Child Health Care Hospital

Guankou, Hunan, 410399, China

Location

Related Publications (10)

• Li HT, Trasande L, Zhu LP, Ye RW, Zhou YB, Liu JM. Association of cesarean delivery with anemia in infants and children in 2 large longitudinal Chinese birth cohorts. Am J Clin Nutr. 2015 Mar;101(3):523-9. doi: 10.3945/ajcn.114.092585. Epub 2014 Dec 24.

  PMID: 25733637 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

• Hutton EK, Hassan ES. Late vs early clamping of the umbilical cord in full-term neonates: systematic review and meta-analysis of controlled trials. JAMA. 2007 Mar 21;297(11):1241-52. doi: 10.1001/jama.297.11.1241.

  PMID: 17374818 BACKGROUND

• Perlman JM, Wyllie J, Kattwinkel J, Atkins DL, Chameides L, Goldsmith JP, Guinsburg R, Hazinski MF, Morley C, Richmond S, Simon WM, Singhal N, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 11: Neonatal resuscitation: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2010 Oct 19;122(16 Suppl 2):S516-38. doi: 10.1161/CIRCULATIONAHA.110.971127. No abstract available.

  PMID: 20956259 BACKGROUND

• Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Committee Opinion No.543: Timing of umbilical cord clamping after birth. Obstet Gynecol. 2012 Dec;120(6):1522-6. doi: 10.1097/01.AOG.0000423817.47165.48.

  PMID: 23168790 BACKGROUND

• McCAUSLAND AM, HOLMES F, SCHUMANN WR. Management of cord and placental blood and its effect upon the newborn. Calif Med. 1949 Sep;71(3):190-6.

  PMID: 18137215 BACKGROUND

• SIDDALL RS, CRISSEY RR, KNAPP WL. Effect on cesarean section babies of stripping or milking of the umbilical cords. Am J Obstet Gynecol. 1952 May;63(5):1059-64. doi: 10.1016/0002-9378(52)90546-2. No abstract available.

  PMID: 14923706 BACKGROUND

• Daniel DG, Weerakkody AN. Neonatal prevention of iron deficiency. Blood can be transfused from cord clamped at placental end. BMJ. 1996 Apr 27;312(7038):1102-3. doi: 10.1136/bmj.312.7038.1102d. No abstract available.

  PMID: 8616446 BACKGROUND

• Upadhyay A, Gothwal S, Parihar R, Garg A, Gupta A, Chawla D, Gulati IK. Effect of umbilical cord milking in term and near term infants: randomized control trial. Am J Obstet Gynecol. 2013 Feb;208(2):120.e1-6. doi: 10.1016/j.ajog.2012.10.884. Epub 2012 Oct 31.

  PMID: 23123382 BACKGROUND

• Mercer JS, Erickson-Owens DA. Rethinking placental transfusion and cord clamping issues. J Perinat Neonatal Nurs. 2012 Jul-Sep;26(3):202-17; quiz 218-9. doi: 10.1097/JPN.0b013e31825d2d9a.

  PMID: 22843002 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Umbilical Cord Clamping

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Jianmeng Liu, PhD

  Peking University

  STUDY CHAIR

• Hongtian Li, PhD

  Peking University

  PRINCIPAL INVESTIGATOR

• Yubo Zhou, PhD

  Peking University

  PRINCIPAL INVESTIGATOR

• Qiyun Du, MD

  Hunan Provincial Maternal and Child Health Care Hospital

  PRINCIPAL INVESTIGATOR

• Shujin Zhou, B.S.Med

  Liuyang Maternal and Child Health Care Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Epidemiology and Biostatistics; Director of Institute of Reproductive and Child Health, Peking University; Director of Office for National Maternal and Child Health Statistics of China

Study Record Dates

• First Submitted: August 23, 2016
• First Posted: September 8, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2019
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

CN (2)