Cardiac Output, HighNCT04358822
Hemodynamic Effects of Delayed Umbilical Cord Clamping in Full-term Newborns
A study testing Delayed cord clamping in people with Cardiac Output, High and Cardiac Output, Low, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Output, High, Cardiac Output, Low
- What is being tested?
- Delayed cord clamping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jan 2020to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Cardiac Output, High, Cardiac Output, Low
- Being tested
- Delayed cord clamping
- Medical subject headings
- Cardiac Output, High, Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed cord clampingProcedure or surgery
The umbilical cord will be clamped after specific time intervals
| Study group | Role | What they receive |
|---|---|---|
| 30 second cord clamping | Active comparator | Infants in this group will receive delayed cord clamping for 30 seconds. Receives: Procedure: Delayed cord clamping |
| 120 second cord clamping | Active comparator | Infants in this group will receive delayed cord clamping for 120 seconds. Receives: Procedure: Delayed cord clamping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output
Data imported from the electrical cardiometry device
Measured: at 15 minutes
Stroke volume
Data imported from the electrical cardiometry device
Measured: at 15 minutes
Cardiac index
Data imported from the electrical cardiometry device
Measured: at 15 minutes
Index of contractility
Data imported from the electrical cardiometry device
Measured: at 15 minutes
Heart rate
Data imported from the electrical cardiometry device
Measured: at 15 minutes
Oxygen saturation
Data imported from the electrical cardiometry device
Measured: at 15 minutes
Secondary outcomes (3)
Hemoglobin concentration
Blood sample will be obtained an analyzed
Measured: At 24 hours
Serum glucose concentration
Blood sample will be obtained an analyzed
Measured: At 24 hours
Serum bilirubin concentration
Blood sample will be obtained an analyzed
Measured: At 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start21 Jan 2020
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiac Output, HighStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Reem Mahmoud, Cairo University
- Investigators
- Reem Mahmoud, Principal investigator, Cairo University Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358822
- Sponsor's protocol ID
- MS-305-2019
- Status last verified
- Apr 2020
- First submitted
- 18 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Katheria AC, Wozniak M, Harari D, Arnell K, Petruzzelli D, Finer NN. Measuring cardiac changes using electrical impedance during delayed cord clamping: a feasibility trial. Matern Health Neonatol Perinatol. 2015 May 22;1:15. doi: 10.1186/s40748-015-0016-3. eCollection 2015.
PubMed 27057332Chopra A, Thakur A, Garg P, Kler N, Gujral K. Early versus delayed cord clamping in small for gestational age infants and iron stores at 3 months of age - a randomized controlled trial. BMC Pediatr. 2018 Jul 18;18(1):234. doi: 10.1186/s12887-018-1214-8.
PubMed 30021580Hsu KH, Wu TW, Wang YC, Lim WH, Lee CC, Lien R. Hemodynamic reference for neonates of different age and weight: a pilot study with electrical cardiometry. J Perinatol. 2016 Jun;36(6):481-5. doi: 10.1038/jp.2016.2. Epub 2016 Feb 18.
PubMed 26890553Mercer JS, Erickson-Owens DA, Collins J, Barcelos MO, Parker AB, Padbury JF. Effects of delayed cord clamping on residual placental blood volume, hemoglobin and bilirubin levels in term infants: a randomized controlled trial. J Perinatol. 2017 Mar;37(3):260-264. doi: 10.1038/jp.2016.222. Epub 2016 Dec 8.
PubMed 27929530Soliman RM, Elgendy MM, Said RN, Shaarawy BI, Helal OM, Aly H. A Randomized Controlled Trial of a 30- versus a 120-Second Delay in Cord Clamping after Term Birth. Am J Perinatol. 2024 Apr;41(6):739-746. doi: 10.1055/a-1772-4543. Epub 2022 Feb 15.
PubMed 35170013
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Delayed Umbilical Cord Clamping in Full-term Newborns
- ClinicalTrials.gov ID
- NCT04358822
- Acronym / sponsor ID
- MS-305-2019
- Conditions
- Cardiac Output, High, Cardiac Output, Low
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 second cord clamping | Active comparator | Procedure: Delayed cord clampingInfants in this group will receive delayed cord clamping for 30 seconds. |
| 120 second cord clamping | Active comparator | Procedure: Delayed cord clampingInfants in this group will receive delayed cord clamping for 120 seconds. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Neonates needing any active resuscitation
- In-utero fetal distress
- Suspected perinatal asphyxia
- Major congenital malformations
- Twin or multiple gestation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delayed cord clampingThe umbilical cord will be clamped after specific time intervals | Procedure or surgery | 120 second cord clamping, 30 second cord clamping |
Primary outcome
Cardiac output
Time frame: at 15 minutes
Data imported from the electrical cardiometry device
Stroke volume
Time frame: at 15 minutes
Data imported from the electrical cardiometry device
Cardiac index
Time frame: at 15 minutes
Data imported from the electrical cardiometry device
Index of contractility
Time frame: at 15 minutes
Data imported from the electrical cardiometry device
Heart rate
Time frame: at 15 minutes
Data imported from the electrical cardiometry device
Oxygen saturation
Time frame: at 15 minutes
Data imported from the electrical cardiometry device
3 secondary outcomes
Hemoglobin concentration
Time frame: At 24 hours
Serum glucose concentration
Time frame: At 24 hours
Serum bilirubin concentration
Time frame: At 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
- Background: PubMed 27057332Katheria AC, Wozniak M, Harari D, Arnell K, Petruzzelli D, Finer NN. Measuring cardiac changes using electrical impedance during delayed cord clamping: a feasibility trial. Matern Health Neonatol Perinatol. 2015 May 22;1:15. doi: 10.1186/s40748-015-0016-3. eCollection 2015.
- Background: PubMed 30021580Chopra A, Thakur A, Garg P, Kler N, Gujral K. Early versus delayed cord clamping in small for gestational age infants and iron stores at 3 months of age - a randomized controlled trial. BMC Pediatr. 2018 Jul 18;18(1):234. doi: 10.1186/s12887-018-1214-8.
- Background: PubMed 26890553Hsu KH, Wu TW, Wang YC, Lim WH, Lee CC, Lien R. Hemodynamic reference for neonates of different age and weight: a pilot study with electrical cardiometry. J Perinatol. 2016 Jun;36(6):481-5. doi: 10.1038/jp.2016.2. Epub 2016 Feb 18.
- Background: PubMed 27929530Mercer JS, Erickson-Owens DA, Collins J, Barcelos MO, Parker AB, Padbury JF. Effects of delayed cord clamping on residual placental blood volume, hemoglobin and bilirubin levels in term infants: a randomized controlled trial. J Perinatol. 2017 Mar;37(3):260-264. doi: 10.1038/jp.2016.222. Epub 2016 Dec 8.
- Derived from this study: PubMed 35170013Soliman RM, Elgendy MM, Said RN, Shaarawy BI, Helal OM, Aly H. A Randomized Controlled Trial of a 30- versus a 120-Second Delay in Cord Clamping after Term Birth. Am J Perinatol. 2024 Apr;41(6):739-746. doi: 10.1055/a-1772-4543. Epub 2022 Feb 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reem Mahmoud principal investigator
Cairo University Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed cord clamping in people with Cardiac Output, High and Cardiac Output, Low, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac output (time frame: at 15 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04358822, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.