Clinical trial NCT02892461: Effect of Umbilical Cord Milking on Iron Related Health Outcomes for Cesarean-Delivered Infants
Official title: Effect of Umbilical Cord Milking on Iron Related Health Outcomes for Cesarean-Delivered Infants: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anemia, Iron-Deficiency
Keywords: Anemia, Iron-Deficiency
Cesarean Section
Umbilical Cord Milking
Randomized Controlled Trial
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
name: Hunan Provincial Maternal and Child Health Care Hospital
name: Liuyang Maternal and Child Health Care Hospital
First posted: 2016-09-08
Enrollment: 484
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in infant's serum ferritin (μg/L)
timeFrame: At birth (baseline), 6 and 12 months after birth
Secondary outcomes:
measure: Change in infant's erythrocyte counts (10^12/L)
timeFrame: At birth (baseline), 1, 6 and 12 months after birth
measure: Change in infant's hemoglobin concentration (g/L)
timeFrame: At birth (baseline), 1, 6 and 12 months after birth
measure: Change in infant's hematocrit (%)
timeFrame: At birth (baseline), 1, 6 and 12 months after birth
measure: Change in infant's weight (kg)
timeFrame: At birth (baseline), 1, 6, 12 and 18 months after birth
measure: Change in infant's height (cm)
timeFrame: At birth (baseline), 1, 6, 12 and 18 months after birth
measure: Infant's language development
timeFrame: 18 months old
measure: Infant's mental/behavioral development
timeFrame: 18 months old
measure: Change in infant's transcutaneous bilirubin concentration (mg/dL)
timeFrame: 1 (baseline), 2, 3, 4 and 5 days after birth
measure: Number of infants with neonatal jaundice in the experimental group and the control group
timeFrame: Up to 18 months old
measure: Number of infants with polycythemia in the experimental group and the control group
timeFrame: Up to 18 months old
Other outcomes:
Locations:
city: Changsha
country: China
facility: Hunan Provincial Maternal and Child Health Care Hospital
state: Hunan
city: Liuyang
country: China
facility: Liuyang Maternal and Child Health Care Hospital
state: Hunan
Study officials:
affiliation: Peking University
name: Jianmeng Liu, PhD
role: STUDY_CHAIR
affiliation: Peking University
name: Hongtian Li, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University
name: Yubo Zhou, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hunan Provincial Maternal and Child Health Care Hospital
name: Qiyun Du, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Liuyang Maternal and Child Health Care Hospital
name: Shujin Zhou, B.S.Med
role: PRINCIPAL_INVESTIGATOR
References:
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.
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;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.
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. doi: 10.1001/jama.297.11.1241.
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. No abstract available.
citation: 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.
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.
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. doi: 10.1016/0002-9378(52)90546-2. No abstract available.
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. doi: 10.1136/bmj.312.7038.1102d. No abstract available.
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.
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.