Effect of Umbilical Cord Milking on Iron Related Health Outcomes for Cesarean-Delivered Infants
NCT ID: NCT02892461
Last Updated: 2020-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
484 participants
INTERVENTIONAL
2016-07-31
2019-04-30
Brief Summary
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Detailed Description
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In this study, investigators aim to test whether umbilical cord milking (UCM), a potentially promising strategy for cesarean delivery, can improve iron related health outcomes for cesarean-delivered infants. A total of 450 term pregnant women who are planning to give births by cesarean sections will be enrolled from two hospitals in Hunan province and randomly assigned to either UCM group or control group. Infants will be followed up at 1, 6, 12, 18 months for the evaluation of the impact of UCM on iron deficiency, anemia, as well as growth and the developmental status of language and mental/behavioral outcomes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Umbilical cord milking
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.
Umbilical cord milking
As same as that in arm descriptions.
Routine clinical treatment and care
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.
No interventions assigned to this group
Interventions
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Umbilical cord milking
As same as that in arm descriptions.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
20 Years
55 Years
FEMALE
Yes
Sponsors
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National Natural Science Foundation of China
OTHER_GOV
Hunan Provincial Maternal and Child Health Care Hospital
OTHER
Liuyang Maternal and Child Health Care Hospital
UNKNOWN
Peking University
OTHER
Responsible Party
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Jianmeng Liu
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
Principal Investigators
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Jianmeng Liu, PhD
Role: STUDY_CHAIR
Peking University
Hongtian Li, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University
Yubo Zhou, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University
Qiyun Du, MD
Role: PRINCIPAL_INVESTIGATOR
Hunan Provincial Maternal and Child Health Care Hospital
Shujin Zhou, B.S.Med
Role: PRINCIPAL_INVESTIGATOR
Liuyang Maternal and Child Health Care Hospital
Locations
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Hunan Provincial Maternal and Child Health Care Hospital
Changsha, Hunan, China
Liuyang Maternal and Child Health Care Hospital
Guankou, Hunan, China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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81571517
Identifier Type: -
Identifier Source: org_study_id
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