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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed Clamping | Active Comparator | In this group, the umbilical cord will be clamped 60 seconds after the baby is born. |
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| Early Clamping | Active Comparator | In this group, the umbilical cord will be clamped 15 seconds after the baby is born. |
|
| Milking Clamping | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delayed umbilical cord clamping | Procedure | The umbilical cord will be clamped 60 seconds after the baby is born. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postpartum maternal hemorrhage | Preoperative and postoperative hemoglobin values will be recorded. | On postoperative day 0 and day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Postpartum maternal anemia | Blood loss during surgery, need for blood transfusion after surgery will be recorded. | İn postpartum 48 hours |
| Neonatal outcomes | Weight of the baby |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mete Gungor, MD, Prof. | Acıbadem Mehmet Ali Aydınlar University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acibadem Maslak Hospital | Istanbul | Sariyer | 34457 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28002310 | Background | Committee Opinion No. 684: Delayed Umbilical Cord Clamping After Birth. Obstet Gynecol. 2017 Jan;129(1):1. doi: 10.1097/AOG.0000000000001860. | |
| 22843002 | Background | 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. |
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Study protocol, statistical analysis might be shared when the study is completed upon request.
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| ID | Term |
|---|---|
| D000087526 | Umbilical Cord Clamping |
| ID | Term |
|---|---|
| D036861 | Delivery, Obstetric |
| D013513 | Obstetric Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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Prospective randomized
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| Early umbilical cord clamping | Procedure | The umbilical cord will be clamped 15 seconds after the baby is born. |
|
| Milking of the umbilical cord | Procedure | The cord will be milked 5 times with 2 seconds milking, then letting 2 seconds for spontaneous blood flow. |
|
| Postpartum day 0 |
| Postpartum complaints | Postpartum nausea, vomiting, headache, dyspnea will be recorded | İn postpartum 48 hours |
| Neonatal anemia | Hematocrit levels of the newborn will be measured | On postpartum day 2 |
| Neonatal jaundice | Bilirubin levels of the newborn will be measured. | On postpartum day 2 |
| Neonatal intensive care unit admission | Neonatal intensive care unit admissions in postpartum 5 days will be recorded. | In postpartum 5 days |
| Maternal outcomes | Postpartum maternal blood pressure, pulse will be recorded | On postpartum day 2 |
| Newborn phototherapy need | Need of newborn phototherapy in postpartum 2 weeks will be recorded. | In postpartum 2 weeks |
| Newborn positive pressure ventilation | Need of newborn positive pressure ventilation in postpartum 5 days will be recorded. | Postpartum 5 days |
| 23843134 | Background | 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. |
| 32607000 | Background | 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. |
| 31742629 | Background | 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. |
| 31203386 | Background | 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. |