Clinical Trial: Milking Versus Delayed Cord Clamping in Full Term Neonates
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Milking Versus Delayed Cord Clamping in Full Term Neonates Delivered by Elective Cesarean Section A Randomized Controlled Trial
Brief Summary: 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 Summary:
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).
Sponsor: Ahmed Mohamed El Kotb Abdel Fattah
Current Primary Outcome: Neonatal Hemoglobin Level [ Time Frame: 6 weeks after labor ]
Original Primary Outcome: hemoglobin level [ Time Frame: 24 hours after labor ]
Current Secondary Outcome:
- Jundice Requring Phtotherapy [ Time Frame: two weks ]number of infants requiring phtotherapy for jundice in the first 2 weeks
- Severe Postpartum Haemorrage [ Time Frame: 24 hours after labor ](measured blood loss 1000 mL or more
- Neonatal Intubation [ Time Frame: 1st 2 hours after delivery ]number of newborns requirng intubation in the first 2 hours after delivery
- Neonatal Intensive Care Unit (NICU) Admission [ Time Frame: 1st 24 hours after delivery ]number of Neonatal Intensive Care unit (NICU) admission in the 1st 24 hours after delivery
- Neonatal Apgar Score (After 5 Minutes of Delivery). [ Time Frame: 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
- Maternal Need for Blood Transfusion. [ Time Frame: 1st 24 hours after delivery ]number of mothers with hemoglobin level < 7mg/dl and need for blood transfusion
- Maternal Additional Need for Therapeutic Uterotonics [ Time Frame: 1st 24 hours of delivery ]number of mothers need for > 20 units of Oxycontin in the 1st 24 hours of delivery
- Duration of Third Stage of Labor [ Time Frame: immediatly after delivery ]number of minutes from delivery of the baby till delivery of the placenta
Original Secondary Outcome:
- hematocrit [ Time Frame: 24 hours after labor ]24 hours hematocrit
- total bilirubin [ Time Frame: 24hours after labor ]24 hours bilirubin
- Neonatal Intensive Care Unit (NICU) Admission [ Time Frame: 24 hours after labor ]NICU
- post partum hemorrhage(PPH) [ Time Frame: 24 hours after labor ]PPH
Information By: Ain Shams University
Dates:
Date Received: May 17, 2015
Date Started: August 2015
Date Completion:
Last Updated: May 19, 2016
Last Verified: April 2016
