An interventional study of Delayed umbilical cord clamping and Early umbilical cord clamping in Cesarean Delivery and Delayed Separation of Umbilical Cord, sponsored by Acibadem University. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-03.
Sponsored by Acibadem University · Not applicable, Interventional, and Supportive care
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.
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.
Acibadem University is the lead sponsor of 210 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
In this group, the umbilical cord will be clamped 60 seconds after the baby is born.
Procedure: Delayed umbilical cord clamping
In this group, the umbilical cord will be clamped 15 seconds after the baby is born.
Procedure: Early umbilical cord clamping
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.
Procedure: Milking of the umbilical cord
The umbilical cord will be clamped 60 seconds after the baby is born.
The umbilical cord will be clamped 15 seconds after the baby is born.
The cord will be milked 5 times with 2 seconds milking, then letting 2 seconds for spontaneous blood flow.
Postpartum maternal hemorrhage
Preoperative and postoperative hemoglobin values will be recorded.
Time frame: On postoperative day 0 and day 2
Postpartum maternal anemia
Blood loss during surgery, need for blood transfusion after surgery will be recorded.
Time frame: İn postpartum 48 hours
Neonatal outcomes
Weight of the baby
Time frame: Postpartum day 0
Postpartum complaints
Postpartum nausea, vomiting, headache, dyspnea will be recorded
Time frame: İn postpartum 48 hours
Neonatal anemia
Hematocrit levels of the newborn will be measured
Time frame: On postpartum day 2
Neonatal jaundice
Bilirubin levels of the newborn will be measured.
Time frame: On postpartum day 2
Neonatal intensive care unit admission
Neonatal intensive care unit admissions in postpartum 5 days will be recorded.
Time frame: In postpartum 5 days
Maternal outcomes
Postpartum maternal blood pressure, pulse will be recorded
Time frame: On postpartum day 2
Newborn phototherapy need
Need of newborn phototherapy in postpartum 2 weeks will be recorded.
Time frame: In postpartum 2 weeks
Newborn positive pressure ventilation
Need of newborn positive pressure ventilation in postpartum 5 days will be recorded.
Time frame: Postpartum 5 days
Plan to share: No — Study protocol, statistical analysis might be shared when the study is completed upon request.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Acibadem University