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Completed

NCT Number: NCT04358822

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

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.

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Key information

Conditions

Cardiac Output, High Cardiac Output, Low Cardiovascular Diseases Heart Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University Children's Hospital

Cairo, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Delayed Cord Clamping

Procedure

The umbilical cord will be clamped after specific time intervals

Primary outcomes

  1. Cardiac output

    Time frame: at 15 minutes

    Data imported from the electrical cardiometry device

  2. Stroke volume

    Time frame: at 15 minutes

    Data imported from the electrical cardiometry device

  3. Cardiac index

    Time frame: at 15 minutes

    Data imported from the electrical cardiometry device

  4. Index of contractility

    Time frame: at 15 minutes

    Data imported from the electrical cardiometry device

  5. Heart rate

    Time frame: at 15 minutes

    Data imported from the electrical cardiometry device

  6. Oxygen saturation

    Time frame: at 15 minutes

    Data imported from the electrical cardiometry device

Secondary outcomes

  1. Hemoglobin concentration

    Time frame: At 24 hours

    Blood sample will be obtained an analyzed

  2. Serum glucose concentration

    Time frame: At 24 hours

    Blood sample will be obtained an analyzed

  3. Serum bilirubin concentration

    Time frame: At 24 hours

    Blood sample will be obtained an analyzed

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2020
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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