Timing of Umbilical Cord Clamping in Term Cesarean Deliveries

Not Applicable

Completed

• Conditions: Cesarean Delivery; Delayed Separation of Umbilical Cord

• Registration Number: NCT04812223
• Lead Sponsor: Acibadem University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-23
• Study Start: 2021-03-25
• Status Verified: 2021-07
• Primary Completion: 2021-07-25
• Study Completion: 2021-07-29
• Last Update Submitted: 2021-07-31
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postpartum maternal hemorrhage	On postoperative day 0 and day 2	Preoperative and postoperative hemoglobin values will be recorded.

Secondary Outcome Measures

Name	Time	Method
Neonatal anemia	On postpartum day 2	Hematocrit levels of the newborn will be measured
Newborn positive pressure ventilation	Postpartum 5 days	Need of newborn positive pressure ventilation in postpartum 5 days will be recorded.
Postpartum maternal anemia	İn postpartum 48 hours	Blood loss during surgery, need for blood transfusion after surgery will be recorded.
Neonatal outcomes	Postpartum day 0	Weight of the baby
Newborn phototherapy need	In postpartum 2 weeks	Need of newborn phototherapy in postpartum 2 weeks will be recorded.
Postpartum complaints	İn postpartum 48 hours	Postpartum nausea, vomiting, headache, dyspnea will be recorded
Neonatal jaundice	On postpartum day 2	Bilirubin levels of the newborn will be measured.
Neonatal intensive care unit admission	In postpartum 5 days	Neonatal intensive care unit admissions in postpartum 5 days will be recorded.
Maternal outcomes	On postpartum day 2	Postpartum maternal blood pressure, pulse will be recorded

Trial Locations

Locations (1)

Acibadem Maslak Hospital; 🇹🇷 Istanbul, Sariyer, Turkey