Hemodynamic Effects of Delayed Umbilical Cord Clamping in Full-term Newborns

April 21, 2020 updated by: Dr. Reem Mahmoud, Cairo University

The sequence of events at the time of delivery includes delivery of the infant, clamping of the umbilical cord, and lastly delivery of the placenta. There are some benefits for delayed cord clamping. This study aims to compare the effects of two different duration of delayed cord clamping.

Infants will be randomized into two groups based on the duration of delayed cord clamping: 30 seconds vs 120 seconds. Different hemodynamic effects will be measured in each group at different time intervals. The hypothesis of the study is that delayed cord clamping for 120 seconds is associated with better cardiac output and with other hemodynamic advantages.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will include full term infants delivered via cesarean section. Written informed consent for participation in the study will be obtained from parents prior to delivery. Newborns will be randomly assigned into two groups according to the duration of cord clamping: Group 1: the cord will be clamped at 30 seconds, and Group 2: the cord will be clamped at 120 seconds of life. Stopwatch will be started when infants buttocks (or head if breech) are delivered from the uterus. The time elapsed will be counted aloud by the investigator in 10-second intervals. During this time, the infant will be held in linen on the mothers legs. Care will be taken not to apply traction on the cord. Milking of the cord will not be allowed. Immediately after resuscitation, infants will be attached to the leads of the electrical cardiometry device. Device output will be imported at 5, 10, and 15 minutes after birth in both groups. A follow up measurement will be imported later at 24 hours of age. In addition, a peripheral blood sample will be obtained at 24 hours of age for assessment of hemoglobin, glucose and bilirubin concentrations. .

The calculated sample size is 31 newborns in each group. This number will be adequate to detect an effect size of 10% in the mean cardiac output between the two groups with 95% confidence and 80% power. The study plans to recruit 34 infants in each group (10% attrition rate).

Study Type

Interventional

Enrollment (Actual)

68

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
      • Cairo, Egypt
        • Cairo University Children'S Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normal full term newborns ≥37 weeks gestational age
  • Both genders are included
  • Singleton
  • Delivered by elective cesarean section due to previous cesarean section, cephalo-pelvic disproportion, or mal-presentation
  • Successfully transitioned without need for respiratory or medication support

Exclusion Criteria:

  • Neonates needing any active resuscitation
  • In-utero fetal distress
  • Suspected perinatal asphyxia
  • Major congenital malformations
  • Twin or multiple gestation
  • Intrauterine growth restriction
  • Placenta previa
  • Mothers with cardiac disorders

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 30 second cord clamping
Infants in this group will receive delayed cord clamping for 30 seconds.
Procedure: Delayed cord clamping
The umbilical cord will be clamped after specific time intervals
Active Comparator: 120 second cord clamping
Infants in this group will receive delayed cord clamping for 120 seconds.
Procedure: Delayed cord clamping
The umbilical cord will be clamped after specific time intervals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac output
Time Frame: at 15 minutes
Data imported from the electrical cardiometry device
at 15 minutes
Stroke volume
Time Frame: at 15 minutes
Data imported from the electrical cardiometry device
at 15 minutes
Cardiac index
Time Frame: at 15 minutes
Data imported from the electrical cardiometry device
at 15 minutes
Index of contractility
Time Frame: at 15 minutes
Data imported from the electrical cardiometry device
at 15 minutes
Heart rate
Time Frame: at 15 minutes
Data imported from the electrical cardiometry device
at 15 minutes
Oxygen saturation
Time Frame: at 15 minutes
Data imported from the electrical cardiometry device
at 15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin concentration
Time Frame: At 24 hours
Blood sample will be obtained an analyzed
At 24 hours
Serum glucose concentration
Time Frame: At 24 hours
Blood sample will be obtained an analyzed
At 24 hours
Serum bilirubin concentration
Time Frame: At 24 hours
Blood sample will be obtained an analyzed
At 24 hours

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Reem Mahmoud, Cairo University Children'S Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 21, 2020

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

April 18, 2020

First Submitted That Met QC Criteria

April 21, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 21, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-305-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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