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

Anemia, Iron-Deficiency Clinical Trial

Official title:

Effect of Umbilical Cord Milking on Iron Related Health Outcomes for Cesarean-Delivered Infants: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892461
• Other study ID #: 81571517
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: April 2019

Study information

• Verified date: March 2020
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

In recent years, several professional organizations have recommended delayed cord clamping to improve placental transfusion for newborns born vaginally based on a series of randomized controlled studies. However, no similar recommendations are available for cesarean-delivered infants. Investigators found that cesarean-delivered infants were more vulnerable to iron deficiency and anemia compared with those born vaginally, suggesting that it is urgently needed to find a similar anemia prevention strategy for infants born by cesarean sections.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: April 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency

Intervention

Procedure:
• Umbilical cord milking
As same as that in arm descriptions.

Locations

Country	Name	City	State
China	Hunan Provincial Maternal and Child Health Care Hospital	Changsha	Hunan
China	Liuyang Maternal and Child Health Care Hospital	Liuyang	Hunan

Sponsors (4)

Lead Sponsor	Collaborator
Peking University	Hunan Provincial Maternal and Child Health Care Hospital, Liuyang Maternal and Child Health Care Hospital, National Natural Science Foundation of China

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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;(7):CD004074. doi: 10.1002/14651858.CD004074.pub3. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in infant's erythrocyte counts (10^12/L)	At birth (baseline)-1 ml umbilical cord blood, 1 month old-20 µL infant's peripheral blood of finger, 6 and 12 months old-1 ml infants' venous blood for each measure.	At birth (baseline), 1, 6 and 12 months after birth
Secondary	Change in infant's hemoglobin concentration (g/L)	A participant's erythrocyte counts and hemoglobin concentration are detected using the same blood sample.	At birth (baseline), 1, 6 and 12 months after birth
Secondary	Change in infant's hematocrit (%)	A participant's erythrocyte counts, hemoglobin concentration and hematocrit are detected using the same blood sample.	At birth (baseline), 1, 6 and 12 months after birth
Secondary	Change in infant's weight (kg)	Every infant's weight will be measured twice each time, but if the difference between the two measurement results is more than 0.1 kg, it will be measured for the third time.	At birth (baseline), 1, 6, 12 and 18 months after birth
Secondary	Change in infant's height (cm)	Every infant's height will be measured twice each time, but if the difference between the two measurement results is more than 0.5 cm, it will be measured for the third time.	At birth (baseline), 1, 6, 12 and 18 months after birth
Secondary	Infant's language development	The infant's development status of language will be assessed by the Language Developmental Survey (LDS).	18 months old
Secondary	Infant's mental/behavioral development	The infant's mental/behavioral development will be assessed by the Child Behavior Checklist (CBCL).	18 months old
Secondary	Change in infant's transcutaneous bilirubin concentration (mg/dL)	An infant's transcutaneous bilirubin concentration will be detected for five days after birth with time recorded. To ensure accuracy, each time it will be repeatedly detected for three times.	1 (baseline), 2, 3, 4 and 5 days after birth
Secondary	Number of infants with neonatal jaundice in the experimental group and the control group	At each follow-up visit (1, 6, 12 and 18 months after birth), parents will be asked whether their children suffer from jaundice up to then. If so, the doctor will ask them about the onset time, possible causes, treatment and prognosis of the disease.	Up to 18 months old
Secondary	Number of infants with polycythemia in the experimental group and the control group	At each follow-up visit (1, 6, 12 and 18 months after birth), parents will be asked whether their children suffer from polycythemia up to then.	Up to 18 months old