Timing of Umbilical Cord Clamping in Term Cesarean Deliveries

Study Overview
=================
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.

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

Conditions
-----------------
Cesarean Delivery, Delayed Separation of Umbilical Cord

Intervention / Treatment
-----------------
* Procedure: Delayed umbilical cord clamping
* Procedure: Early umbilical cord clamping
* Procedure: Milking of the umbilical cord


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Delayed Clamping<br>In this group, the umbilical cord will be clamped 60 seconds after the baby is born. | Procedure: Delayed umbilical cord clamping<br>* The umbilical cord will be clamped 60 seconds after the baby is born.<br>|
| Active Comparator: Early Clamping<br>In this group, the umbilical cord will be clamped 15 seconds after the baby is born. | Procedure: Early umbilical cord clamping<br>* The umbilical cord will be clamped 15 seconds after the baby is born.<br>|
| Active Comparator: Milking Clamping<br>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<br>* The cord will be milked 5 times with 2 seconds milking, then letting 2 seconds for spontaneous blood flow.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum maternal hemorrhage | Preoperative and postoperative hemoglobin values will be recorded. | On postoperative day 0 and day 2 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cesarean delivery, Umbilical cord clamping, Delayed umbilical cord clamping