ClinicalTrials.gov
ClinicalTrials.gov Menu

Milking Versus Delayed Cord Clamping in Full Term Neonates (MDCCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02454101
Recruitment Status : Completed
First Posted : May 27, 2015
Results First Posted : June 28, 2016
Last Update Posted : June 28, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University

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.

Condition or disease Intervention/treatment Phase
Neonatal Anemia Procedure: cord milking Procedure: delayed cord clamping Not Applicable

Detailed Description:

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
Allocation: Randomized
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

Arm Intervention/treatment
cord milking
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



Primary Outcome Measures :
  1. Neonatal Hemoglobin Level [ Time Frame: 6 weeks after labor ]
    neonatal 6 weeks hemoglobin measured in gram %


Secondary Outcome Measures :
  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:

      1. Breathing effort
      2. Heart rate
      3. Muscle tone
      4. Reflexes
      5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
Egypt
Ain Chams University Maternity Hospital
Cairo, Egypt, 02
Sponsors and Collaborators
Ahmed Mohamed El Kotb Abdel Fattah
Investigators
Principal Investigator: Hazem F El Shahawy, PHD clinical professor

Publications:
Inch S. Management of the third stage of labour: another cascade of intervention?. Midwifery 1985;1:114-22.
.McDonald S. Physiology and management of the third stage of labour. In: Fraser D, Cooper M editor(s). Myles textbook for mid- wives. 14th Edition. Edinburgh: Churchill Livingstone, 2003.
.Prendiville W, Elbourne D. Care during the third stage of labour. In: Chalmers I, Enkin M, Keirse MJNC editor(s). Effective care in pregnancy and childbirth. Oxford: Oxford University Press, 1989: 1145-69.
.Smith J, Brennan BG. Management of the third stage of labor. EMedicine from WebMD (last updated 27 June 2006) (accessed 28 January 2007).

Responsible Party: Ahmed Mohamed El Kotb Abdel Fattah, Principal Investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT02454101     History of Changes
Other Study ID Numbers: delayed cord clamping in term
First Posted: May 27, 2015    Key Record Dates
Results First Posted: June 28, 2016
Last Update Posted: June 28, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: lecture and seminar

Additional relevant MeSH terms:
Anemia, Neonatal
Anemia
Hematologic Diseases
Infant, Newborn, Diseases