Milking Versus Delayed Cord Clamping in Full Term Neonates

Study Overview
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Brief Summary
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To compare the short term risks and benefits of cord milking 5 times toward the neonate with delayed cord clamping for 120 seconds in the full term neonate delivered by cesarean section.

Detailed Description
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Abstract Context: milking of the umbilical cord toward the neonate 5 times and delayed cord clamping both are good procedures to prevent anemia in neonates . Objective: To investigate the effects of delayed umbilical cord clamping for 120 seconds, compared with milking of the cord 5 times toward the neonate on hemoglobin level after 6 weeks, Intubation,Respiratory distress,Clinical jaundice,Neonatal Intensive Care unit (NICU) admission,Apgar score (after 5 minutes of delivery). -Maternal,Need for blood transfusion,Additional need for therapeutic uterotonics,Post postpartum hemorrhage (blood loss > 500cc),Intensive Care unit admission. Design: Randomized controlled trial. Setting: Ain Shams university maternity hospital. Participants:300 full term infants born after a low risk pregnancy by cesarean section delivery. Intervention: Infants were randomized to delayed umbilical cord clamping (≥120 seconds after delivery) or cord milking (5 times to ward the neonate).

Official Title
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Milking Versus Delayed Cord Clamping in Full Term Neonates Delivered by Elective Cesarean Section A Randomized Controlled Trial

Conditions
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Neonatal Anemia

Intervention / Treatment
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* Procedure: cord milking
* Procedure: delayed cord clamping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant females going for cesarean section that completed 37 weeks of gestation Medically free Exclusion Criteria: Known congenital anomalies of fetus. Rhesus sensitization. Fetal hydrops. Medical disorder (preeclampsia - diabetes mellitus - hypertension - SLE). Need for urgent resuscitation. Multiple pregnancies.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: cord milking<br>milking of the umbilical cord 5 times toward the neonate | Procedure: delayed cord clamping<br>* delay clamping of the cord for 120 seconds<br>|
| Other: delayed cord clamping<br>delayed cord clamping for 120 seconds | Procedure: cord milking<br>* milking of the cord 5 times toward the neonate<br>* Other names: milking of the cord;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neonatal Hemoglobin Level | neonatal 6 weeks hemoglobin measured in gram % | 6 weeks after labor | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jundice Requring Phtotherapy | number of infants requiring phtotherapy for jundice in the first 2 weeks | two weks | 
| Severe Postpartum Haemorrage | (measured blood loss 1000 mL or more | 24 hours after labor | 
| Neonatal Intubation | number of newborns requirng intubation in the first 2 hours after delivery | 1st 2 hours after delivery | 
| Neonatal Intensive Care Unit (NICU) Admission | number of Neonatal Intensive Care unit (NICU) admission in the 1st 24 hours after delivery | 1st 24 hours after delivery | 
| Neonatal Apgar Score (After 5 Minutes of Delivery). | The Apgar test is done by a doctor, midwife, or nurse. The health care provider examines the baby's: Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health. A score of 10 is very unusual, since almost all newborns lose 1 point for blue hands and feet, which is normal for after birth. Any score lower than 7 is a sign that the baby needs medical attention. The lower the score, the more help the baby needs | 5 minutes of delivery | 
| Maternal Need for Blood Transfusion. | number of mothers with hemoglobin level < 7mg/dl and need for blood transfusion | 1st 24 hours after delivery | 
| Maternal Additional Need for Therapeutic Uterotonics | number of mothers need for > 20 units of Oxycontin in the 1st 24 hours of delivery | 1st 24 hours of delivery | 
| Duration of Third Stage of Labor | number of minutes from delivery of the baby till delivery of the placenta | immediatly after delivery |