Timing of Umbilical Cord Clamping in Term Cesarean Deliveries

Cesarean Delivery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04812223
• Other study ID #: ATADEK 2021-01/44
• Status: Completed
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: July 29, 2021

Study information

• Verified date: July 2021
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: July 29, 2021
• Est. primary completion date: July 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

• In case of meconium aspiration syndrome suspicion

Related Conditions & MeSH terms

• Cesarean Delivery
• Delayed Separation of Umbilical Cord

Intervention

Procedure:
• Delayed umbilical cord clamping
The umbilical cord will be clamped 60 seconds after the baby is born.
• Early umbilical cord clamping
The umbilical cord will be clamped 15 seconds after the baby is born.
• Milking of the umbilical cord
The cord will be milked 5 times with 2 seconds milking, then letting 2 seconds for spontaneous blood flow.

Locations

Country	Name	City	State
Turkey	Acibadem Maslak Hospital	Istanbul	Sariyer

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Committee Opinion No. 684: Delayed Umbilical Cord Clamping After Birth. Obstet Gynecol. 2017 Jan;129(1):1. doi: 10.1097/AOG.0000000000001860. — View 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;(7):CD004074. doi: 10.1002/14651858.CD004074.pub3. Review. — View 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. Review. — View Citation

Purisch SE, Ananth CV, Arditi B, Mauney L, Ajemian B, Heiderich A, Leone T, Gyamfi-Bannerman C. Effect of Delayed vs Immediate Umbilical Cord Clamping on Maternal Blood Loss in Term Cesarean Delivery: A Randomized Clinical Trial. JAMA. 2019 Nov 19;322(19):1869-1876. doi: 10.1001/jama.2019.15995. — View Citation

Qian Y, Ying X, Wang P, Lu Z, Hua Y. Early versus delayed umbilical cord clamping on maternal and neonatal outcomes. Arch Gynecol Obstet. 2019 Sep;300(3):531-543. doi: 10.1007/s00404-019-05215-8. Epub 2019 Jun 15. Review. — View Citation

Songthamwat M, Witsawapaisan P, Tanthawat S, Songthamwat S. Effect of Delayed Cord Clamping at 30 Seconds and 1 Minute on Neonatal Hematocrit in Term Cesarean Delivery: A Randomized Trial. Int J Womens Health. 2020 Jun 23;12:481-486. doi: 10.2147/IJWH.S248709. eCollection 2020. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postpartum maternal hemorrhage	Preoperative and postoperative hemoglobin values will be recorded.	On postoperative day 0 and day 2
Secondary	Postpartum maternal anemia	Blood loss during surgery, need for blood transfusion after surgery will be recorded.	In postpartum 48 hours
Secondary	Neonatal outcomes	Weight of the baby	Postpartum day 0
Secondary	Postpartum complaints	Postpartum nausea, vomiting, headache, dyspnea will be recorded	In postpartum 48 hours
Secondary	Neonatal anemia	Hematocrit levels of the newborn will be measured	On postpartum day 2
Secondary	Neonatal jaundice	Bilirubin levels of the newborn will be measured.	On postpartum day 2
Secondary	Neonatal intensive care unit admission	Neonatal intensive care unit admissions in postpartum 5 days will be recorded.	In postpartum 5 days
Secondary	Maternal outcomes	Postpartum maternal blood pressure, pulse will be recorded	On postpartum day 2
Secondary	Newborn phototherapy need	Need of newborn phototherapy in postpartum 2 weeks will be recorded.	In postpartum 2 weeks
Secondary	Newborn positive pressure ventilation	Need of newborn positive pressure ventilation in postpartum 5 days will be recorded.	Postpartum 5 days