Timing of Umbilical Cord Clamping in Term Cesarean Deliveries
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Delayed Clamping In this group, the umbilical cord will be clamped 60 seconds after the baby is born. |
Procedure: Delayed umbilical cord clamping
The umbilical cord will be clamped 60 seconds after the baby is born.
|
| Active Comparator: Early Clamping In this group, the umbilical cord will be clamped 15 seconds after the baby is born. |
Procedure: Early umbilical cord clamping
The umbilical cord will be clamped 15 seconds after the baby is born.
|
| Active Comparator: Milking 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 cord will be milked 5 times with 2 seconds milking, then letting 2 seconds for spontaneous blood flow.
|
Outcome Measures
Primary Outcome Measures
- Postpartum maternal hemorrhage [On postoperative day 0 and day 2]
Preoperative and postoperative hemoglobin values will be recorded.
Secondary Outcome Measures
- 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
- Postpartum complaints [İn postpartum 48 hours]
Postpartum nausea, vomiting, headache, dyspnea will be recorded
- Neonatal anemia [On postpartum day 2]
Hematocrit levels of the newborn will be measured
- 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
- Newborn phototherapy need [In postpartum 2 weeks]
Need of newborn phototherapy in postpartum 2 weeks will be recorded.
- Newborn positive pressure ventilation [Postpartum 5 days]
Need of newborn positive pressure ventilation in postpartum 5 days will be recorded.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
37 weeks uncomplicated singleton pregnancy
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Elective cesarean delivery
-
Cesarean section under regional anesthesia
Exclusion Criteria:
-
< 37 weeks pregnancy
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Surgery performed under general anesthesia
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Emergent cesarean
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Multiple pregnancy
-
Medically unstable mother or fetus
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Uncontrolled maternal diabetes
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Major congenital malformation of chromosomal abnormality of the fetus
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Intrauterine growth retardation
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Prenatal asphyxia suspicion
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True knot in the umbilical cord
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İn case of meconium aspiration syndrome suspicion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Acibadem Maslak Hospital | Istanbul | Sariyer | Turkey | 34457 |
Sponsors and Collaborators
- Acibadem University
Investigators
- Study Director: Mete Gungor, MD, Prof., Acıbadem Mehmet Ali Aydınlar University
Study Documents (Full-Text)
None provided.More Information
Publications
- Committee Opinion No. 684: Delayed Umbilical Cord Clamping After Birth. Obstet Gynecol. 2017 Jan;129(1):1. doi: 10.1097/AOG.0000000000001860.
- 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.
- 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.
- 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.
- 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.
- 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.
- ATADEK 2021-01/44