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

July 20, 2023 updated by: Alexandria University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Tamer Ahmed Hosny

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Umbilical cord milking

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemoglobin level
Time Frame: immediately after the intervention
a blood sample is taken from the umbilical cord of the neonate
immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bilirubin level
Time Frame: 72 hours after delivery
trans-cutaneous measurement of the bilirubin level
72 hours after delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2021

Primary Completion (Actual)

June 20, 2022

Study Completion (Actual)

June 20, 2022

Study Registration Dates

First Submitted

July 6, 2023

First Submitted That Met QC Criteria

July 16, 2023

First Posted (Actual)

July 19, 2023

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0106748

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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