Clinical trial NCT04812223: Timing of Umbilical Cord Clamping in Term Cesarean Deliveries
Official title: Prospective Randomized Comparison of the Results of Early Clamping, Delayed Clamping and Milking of the Umbilical Cord in Term Cesarean Deliveries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Delivery
Delayed Separation of Umbilical Cord
Keywords: Cesarean delivery
Umbilical cord clamping
Delayed umbilical cord clamping
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 204
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postpartum maternal hemorrhage
timeFrame: On postoperative day 0 and day 2
Secondary outcomes:
measure: Postpartum maternal anemia
timeFrame: İn postpartum 48 hours
measure: Neonatal outcomes
timeFrame: Postpartum day 0
measure: Postpartum complaints
timeFrame: İn postpartum 48 hours
measure: Neonatal anemia
timeFrame: On postpartum day 2
measure: Neonatal jaundice
timeFrame: On postpartum day 2
measure: Neonatal intensive care unit admission
timeFrame: In postpartum 5 days
measure: Maternal outcomes
timeFrame: On postpartum day 2
measure: Newborn phototherapy need
timeFrame: In postpartum 2 weeks
measure: Newborn positive pressure ventilation
timeFrame: Postpartum 5 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem Maslak Hospital
state: Sariyer
Study officials:
affiliation: Acıbadem Mehmet Ali Aydınlar University
name: Mete Gungor, MD, Prof.
role: STUDY_DIRECTOR
References:
citation: Committee Opinion No. 684: Delayed Umbilical Cord Clamping After Birth. Obstet Gynecol. 2017 Jan;129(1):1. doi: 10.1097/AOG.0000000000001860.
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.
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;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.
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.
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.
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.