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NCT Number: NCT02454101

Milking Versus Delayed Cord Clamping in Full Term Neonates

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.

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Key information

Conditions

Neonatal Anemia Anemia Anemia, Neonatal Congenital, Hereditary, and Neonatal Diseases and Abnormalities Hematologic Diseases Hemic and Lymphatic Diseases Infant, Newborn, Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain Chams University Maternity Hospital

Cairo, Cairo Governorate, 02, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cord Milking

Procedure

milking of the cord 5 times toward the neonate

Other names: milking of the cord

Delayed Cord Clamping

Procedure

delay clamping of the cord for 120 seconds

Primary outcomes

  1. Neonatal Hemoglobin Level

    Time frame: 6 weeks after labor

    neonatal 6 weeks hemoglobin measured in gram %

Secondary outcomes

  1. Jundice Requring Phtotherapy

    Time frame: two weks

    number of infants requiring phtotherapy for jundice in the first 2 weeks

  2. Severe Postpartum Haemorrage

    Time frame: 24 hours after labor

    (measured blood loss 1000 mL or more

  3. Neonatal Intubation

    Time frame: 1st 2 hours after delivery

    number of newborns requirng intubation in the first 2 hours after delivery

  4. 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

  5. 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

  6. 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

  7. 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

  8. Duration of Third Stage of Labor

    Time frame: immediatly after delivery

    number of minutes from delivery of the baby till delivery of the placenta

Sponsors and collaborators

Lead sponsor

Ahmed Mohamed El Kotb Abdel Fattah

Other

Registry information

Official study title

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

Acronym: MDCCT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 27, 2015
Registry last updated
Jun 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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