Milking Versus Delayed Cord Clamping in Full Term Neonates (MDCCT)
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|ClinicalTrials.gov Identifier: NCT02454101|
Recruitment Status : Completed
First Posted : May 27, 2015
Results First Posted : June 28, 2016
Last Update Posted : June 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Neonatal Anemia||Procedure: cord milking Procedure: delayed cord clamping||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Milking Versus Delayed Cord Clamping in Full Term Neonates Delivered by Elective Cesarean Section A Randomized Controlled Trial|
|Study Start Date :||August 2015|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
milking of the umbilical cord 5 times toward the neonate
Procedure: delayed cord clamping
delay clamping of the cord for 120 seconds
delayed cord clamping
delayed cord clamping for 120 seconds
Procedure: cord milking
milking of the cord 5 times toward the neonate
Other Name: milking of the cord
- Neonatal Hemoglobin Level [ Time Frame: 6 weeks after labor ]neonatal 6 weeks hemoglobin measured in gram %
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454101
|Ain Chams University Maternity Hospital|
|Cairo, Egypt, 02|
|Principal Investigator:||Hazem F El Shahawy, PHD||clinical professor|