Skip to main content
OpenTrials
Completed

NCT Number: NCT04812223

Timing of Umbilical Cord Clamping in Term Cesarean Deliveries

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Acibadem Maslak Hospital

Istanbul, Sariyer, 34457, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delayed umbilical cord clamping

Procedure

The umbilical cord will be clamped 60 seconds after the baby is born.

Early umbilical cord clamping

Procedure

The umbilical cord will be clamped 15 seconds after the baby is born.

Milking of the umbilical cord

Procedure

The cord will be milked 5 times with 2 seconds milking, then letting 2 seconds for spontaneous blood flow.

Primary outcomes

  1. Postpartum maternal hemorrhage

    Time frame: On postoperative day 0 and day 2

    Preoperative and postoperative hemoglobin values will be recorded.

Secondary outcomes

  1. Postpartum maternal anemia

    Time frame: İn postpartum 48 hours

    Blood loss during surgery, need for blood transfusion after surgery will be recorded.

  2. Neonatal outcomes

    Time frame: Postpartum day 0

    Weight of the baby

  3. Postpartum complaints

    Time frame: İn postpartum 48 hours

    Postpartum nausea, vomiting, headache, dyspnea will be recorded

  4. Neonatal anemia

    Time frame: On postpartum day 2

    Hematocrit levels of the newborn will be measured

  5. Neonatal jaundice

    Time frame: On postpartum day 2

    Bilirubin levels of the newborn will be measured.

  6. Neonatal intensive care unit admission

    Time frame: In postpartum 5 days

    Neonatal intensive care unit admissions in postpartum 5 days will be recorded.

  7. Maternal outcomes

    Time frame: On postpartum day 2

    Postpartum maternal blood pressure, pulse will be recorded

  8. Newborn phototherapy need

    Time frame: In postpartum 2 weeks

    Need of newborn phototherapy in postpartum 2 weeks will be recorded.

  9. Newborn positive pressure ventilation

    Time frame: Postpartum 5 days

    Need of newborn positive pressure ventilation in postpartum 5 days will be recorded.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

Prospective Randomized Comparison of the Results of Early Clamping, Delayed Clamping and Milking of the Umbilical Cord in Term Cesarean Deliveries

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 23, 2021
Registry last updated
Aug 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.