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

• 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: Ahmed Mohamed El Kotb Abdel Fattah
• Information provided by (Responsible Party): Ahmed Mohamed El Kotb Abdel Fattah, Ain Shams University

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• 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.

Contacts and Locations

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

More Information

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• Responsible Party: Ahmed Mohamed El Kotb Abdel Fattah, Principal Investigator, Ain Shams University
• ClinicalTrials.gov Identifier: NCT02454101
• Other Study ID Numbers: delayed cord clamping in term
• First Posted: May 27, 2015
• 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