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

Peking University

Status: Completed

Conditions: Anemia, Iron-Deficiency

Treatments: Procedure: Umbilical cord milking

Study type: Interventional

Funder types: Other

Identifiers

NCT02892461

81571517

Details and patient eligibility

About

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.

Full 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.

Enrollment: 484 patients

Sex: Female

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

484 participants in 2 patient groups

Umbilical cord milking

Experimental group

Description:

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.

Treatment:

Procedure: Umbilical cord milking

Routine clinical treatment and care

No Intervention group

Description:

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.