Timing of Umbilical Cord Clamping in Term Cesarean Deliveries

Acibadem University

Status: Completed

Conditions: Delayed Separation of Umbilical Cord; Cesarean Delivery

Treatments: Procedure: Delayed umbilical cord clamping; Procedure: Milking of the umbilical cord; Procedure: Early umbilical cord clamping

Study type: Interventional

Funder types: Other

Identifiers

NCT04812223

ATADEK 2021-01/44

Details and patient eligibility

About

The aim of this study is to show that delayed umbilical cord clamping or milking of the umbilical cord in pregnant women undergoing elective cesarean delivery might have better effects than early clamping, on neonatal results without causing maternal hemorrhage or negatively affecting the neonatal outcome , and to compare the superiority of these three methods to each other.

Full description

Late clamping of the umbilical cord has been shown to have positive effects such as higher neonatal hemoglobin level, higher iron stores in the newborn around three to six months, and better neurological development. In 2017, American College of Obstetricians and Gynecologists (ACOG) recommended a minimum 30-60 seconds delayed clamping of the cord after a minimum of 30-60 seconds, regardless of the delivery method, in both term and preterm newborns. In addition, optimal placental transfusion can be achieved due to strong uterine tonus in vaginal delivery. However, this is not possible due to decreased uterine tonus and time constraint in cesarean delivery. The main concern in delayed clamping and milking of the umbilical cord is the possibility of maternal anemia due to excessive maternal blood loss in the short term, the need for maternal blood transfusion or maternal intensive care support, and the possibility of conditions such as hyperbilirubinemia, symptomatic polycythemia, and long hospital stay that may cause the need for phototherapy in the newborn. Although there are many studies in the literature regarding the neonatal results of the clamping timing of the umbilical cord, there are a limited number of articles regarding the results in patients who underwent term elective cesarean section. The aim of this study is to show that delayed umbilical cord clamping or milking of the umbilical cord in pregnant women undergoing elective cesarean delivery might have better effects than early clamping, on neonatal results without causing maternal hemorrhage or negatively affecting the neonatal outcome , and to compare the superiority of these three methods to each other.

Enrollment: 204 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• > 37 weeks uncomplicated singleton pregnancy
• Elective cesarean delivery
• Cesarean section under regional anesthesia

Exclusion criteria

• < 37 weeks pregnancy
• Surgery performed under general anesthesia
• Emergent cesarean
• Multiple pregnancy
• Medically unstable mother or fetus
• Uncontrolled maternal diabetes
• Major congenital malformation of chromosomal abnormality of the fetus
• Intrauterine growth retardation
• Prenatal asphyxia suspicion
• True knot in the umbilical cord
• İn case of meconium aspiration syndrome suspicion

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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204 participants in 3 patient groups

Delayed Clamping

Active Comparator group

Description:

In this group, the umbilical cord will be clamped 60 seconds after the baby is born.

Treatment:

Procedure: Delayed umbilical cord clamping

Early Clamping

Active Comparator group

Description:

In this group, the umbilical cord will be clamped 15 seconds after the baby is born.

Treatment:

Procedure: Early umbilical cord clamping

Milking Clamping

Active Comparator group

Description:

In this group in which the umbilical cord will be milked, the cord will be milked 5 times with 2 seconds milking, then letting 2 seconds for spontaneous blood flow.

Treatment:

Procedure: Milking of the umbilical cord