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Comparing Delayed Cord Clamping and Umbilical Cord Milking During Elective Cesarean Section for the Neonatal Outcome

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ClinicalTrials.gov Identifier: NCT05951348
Recruitment Status : Completed
First Posted : July 19, 2023
Last Update Posted : July 21, 2023
Sponsor:
Information provided by (Responsible Party):
Alexandria University

Study Description
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Brief Summary:
the study is conducted on the different actions on umbilical cord clamping including immediate cord clamping (ICC) , delayed cord clamping (DCC) for 30 seconds and umbilical cord milking (UCM) for 10-15 seconds in females that are delivered by elective cesarean section , to assess the neonatal outcomes including Hemoglobin and Hematocrit levels after birth in the newborn and the bilirubin level after 72 hrs

Condition or disease Intervention/treatment Phase
Umbilical Cord Milking Procedure: Delayed cord clamping for 30 seconds Not Applicable

Detailed Description:
the benefit of umbilical cord milking for 10-15 seconds maneuver in cesarean section, that short time can improve the hemoglobin level and prevent anemia in the newborn with improvement of the iron stores for months in infancy without affection on the bilirubin level and the need for phototherapy. This is significant because of the rising rate of cesarean section all over the world make more children are liable for anemia, and by this simple technique it can be prevented.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Comparing Delayed Cord Clamping and Umbilical Cord Milking During Elective Cesarean Section for the Neonatal Outcome
Actual Study Start Date : November 11, 2021
Actual Primary Completion Date : June 20, 2022
Actual Study Completion Date : June 20, 2022

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: Immediate cord clamping
this arm where the patient didn't receive any special maneuver and immediate cord clamping after delivery of the fetus is done
Experimental: Delayed cord clamping
this arm where the patient receive a delay in cord clamping for 30 seconds after delivery of the fetus
 Procedure: Delayed cord clamping for 30 seconds
waiting for 30 seconds after delivery of the fetus or milking of the cord in the direction of the fetus 10 times in time frame 10-15 seconds
Other Name: Umbilical cord milking
Experimental: Umbilical cord milking
this arm where the patient receive stripping of the umbilical cord in the direction of the fetus 10 times in a time frame 10-15 seconds after delivery of the fetus
 Procedure: Delayed cord clamping for 30 seconds
waiting for 30 seconds after delivery of the fetus or milking of the cord in the direction of the fetus 10 times in time frame 10-15 seconds
Other Name: Umbilical cord milking


Outcome Measures
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Primary Outcome Measures :
  1. hemoglobin level [ Time Frame: immediately after the intervention ]
    a blood sample is taken from the umbilical cord of the neonate


Secondary Outcome Measures :
  1. bilirubin level [ Time Frame: 72 hours after delivery ]
    trans-cutaneous measurement of the bilirubin level


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mother's age (20-40) years.
  • pregnancy with a healthy singleton
  • gestational age of 38-41 0/7 weeks
  • uncomplicated pregnancy

Exclusion Criteria

  • Any medical or obstetrical complications like hypertension, pre-eclampsia, diabetes any special habits like smoking, and substance abuse
  • Rh-negative mothers. The fetal exclusion criteria
  • fetus with evidence of intrauterine growth restriction
  • infant with serious congenital anomalies.
Contacts and Locations
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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): NCT05951348


Locations
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Egypt
Tamer Ahmed Hosny
Alexandria, Egypt
Sponsors and Collaborators
Alexandria University
More Information
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Responsible Party: Alexandria University
ClinicalTrials.gov Identifier: NCT05951348    
Other Study ID Numbers: 0106748
First Posted: July 19, 2023    Key Record Dates
Last Update Posted: July 21, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexandria University:
cesarean section
umbilical cord milking
hemoglobin