PreTerm BirthNCT02996799
Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants
A study testing Umbilical cord milking in people with PreTerm Birth and Intraventricular Hemorrhage, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
For preterm infants, deferred cord clamping has been shown to improve both short term and long-term neonatal outcomes without an established harm for both the mother and her infant.The interference with resuscitative measures for the neonate or the mother is a risk that continued to hamper the implementation of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- PreTerm Birth, Intraventricular Hemorrhage
- What is being tested?
- Umbilical cord milking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Jan 2017to Jun 2023
- 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
- Preterm infants < 32 weeks gestation confirmed by first trimester US
Who cannot join
- Any proven or suspected congenital or chromosomal abnormalities
- Placenta previa or abruption
- Cord prolapse
- Known Rh sensitization
- Fetal hydrops
- Monochorionic multiples
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
King Abdulaziz University Hospital
Jeddah
Heidi Al-Wassia, halwassia@kau.edu.sa
About this study
Official title: Efficacy and Safety of Deferred Umbilical Cord Clamping Compared to Umbilical CordMilking in Preterm Infants: A Randomized Clinical Trial
For preterm infants, deferred cord clamping has been shown to improve both short term and long-term neonatal outcomes without an established harm for both the mother and her infant.The interference with resuscitative measures for the neonate or the mother is a risk that continued to hamper the implementation of delayed cord clamping in many centers around the world.For that reason, the evidence now is seeking a time-honored, yet not adopted method of placental transfusion that involves milking of the umbilical cord.
Read the detailed description
Contrary to delayed cord clamping, milking of the umbilical cord is done at a faster rate and in shorter time.Recent evidence has demonstrated the efficacy and safety of umbilical cord milking for both term and preterm infants.A newer evidence comparing delayed cord clamping to umbilical cord milking in preterm infants demonstrated a higher initial hemoglobin, blood pressure and systemic blood flow in preterm infants allocated to the umbilical cord milking arm.However, concerns have been raised with regard to rapid infusion of large volume of blood in relatively shorter time predisposing to hyperperfusion injury including intraventricular hemorrhage. This is particularly problematic for preterm neonates as they are at higher risk of neurological injury. It has, though, advantage of shorter timeframe allowing for effective resuscitation of preterm neonates to start as soon as possible. Thus, with countering advantages and disadvantages, the practice has not been adopted at most places. The authors planned to conduct a randomized clinical trail to compare the efficacy and safety of umbilical cord milking to deferred cord clamping in preterm infants less than 32 weeks gestation.
- Conditions
- PreTerm Birth, Intraventricular Hemorrhage
- Being tested
- Umbilical cord milking
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord milkingOther
Milking of the umbilical cord at delivery
| Study group | Role | What they receive |
|---|---|---|
| Deferred Cord Clamping | No intervention | Neonate is held at the level of placenta (level of introitus (vaginal delivery ) and mother's thigh or operating table (C/S) and cord clamping is deferred for 60 seconds. |
| Umbilical cord milking | Experimental | Manually stripping 20cm of cord segment toward the umbilicus over a period of 2-3 seconds three times before cord clamping. Receives: Other: Umbilical cord milking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraventricular haemorrhage
Any IVH diagnosed by cranial ultrasound
Measured: twenty eight days
Secondary outcomes (20)
Need for resuscitation
Cardiac compression or medications at birth
Measured: one hour
Apgar score at one minute
Calculated Apgar score at one minute
Measured: one minute after delivery
Apgar score at 5 minutes
Calculated Apgar score at 5 minutes
Measured: 5 minutes after delivery
The need for blood transfusion during hospital stay
The number of blood transfusions during hospital stay
Measured: one month
Venous Hgb
Hgb at birth
Measured: 2 days
Venous hematocrit
Hematocrit at birth
Measured: 2 days
Bilirubin level
First bilirubin level after birth
Measured: 24 hours after birth
Maximum bilirubin level
Highest bilirubin level
Measured: first week of life
Polycythemia
If venous hematocrit more than 65%
Measured: first 48 hours after birth
Respiratory distress syndrome
The need for surfactant administration
Measured: 48 hours after birth
Oxygen dependency
first 28 days after birth and/or 36 weeks corrected age
Measured: first 28 days after birth and 36 weeks corrected age
Need for volume administration
Need for bolus administration first 24 hours after birth
Measured: 24 hours after birth
Use of inotropes
Use of any kind of inotropes in the first 24 hours
Measured: First 24 hours
Necrotizing enterocolitis
Bell stage II or more
Measured: one month
Mortality in hospital
Death before discharge
Measured: one month
Sepsis
Positive blood culture
Measured: one month
Maternal mortality
Maternal death after delivery in hospital
Measured: 2 weeks
Post partum hemorrhage
Maternal estimated blood loss more than 500 mls in the first 24 hours after birth
Measured: one day
Maternal need for blood transfusion
Maternal blood transfusion in the first 48 hours after delivery
Measured: First 48 hours after delivery
Length of third stage
The time from delivery of the infant until delivery of placenta
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreTerm BirthStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Al-Wassia, King Abdulaziz University
- Investigators
- Heidi Al-Wassia, MD, Principal investigator, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996799
- Sponsor's protocol ID
- 409-16
- Status last verified
- Sep 2021
- First submitted
- 3 Dec 2016
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: We are planning to publish all the data that we will collect. If other researchers have specific questions about the data, we are willing to answer and share if needed.
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Deferred Umbilical Cord Clamping Compared to Umbilical CordMilking in Preterm Infants: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02996799
- Acronym / sponsor ID
- 409-16
- Conditions
- PreTerm Birth, Intraventricular Hemorrhage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 19 Dec 2016 (estimated)
- 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.
For preterm infants, deferred cord clamping has been shown to improve both short term and long-term neonatal outcomes without an established harm for both the mother and her infant.The interference with resuscitative measures for the neonate or the mother is a risk that continued to hamper the implementation of delayed cord clamping in many centers around the world.For that reason, the evidence now is seeking a time-honored, yet not adopted method of placental transfusion that involves milking of the umbilical cord.
Detailed description
Contrary to delayed cord clamping, milking of the umbilical cord is done at a faster rate and in shorter time.Recent evidence has demonstrated the efficacy and safety of umbilical cord milking for both term and preterm infants.A newer evidence comparing delayed cord clamping to umbilical cord milking in preterm infants demonstrated a higher initial hemoglobin, blood pressure and systemic blood flow in preterm infants allocated to the umbilical cord milking arm.However, concerns have been raised with regard to rapid infusion of large volume of blood in relatively shorter time predisposing to hyperperfusion injury including intraventricular hemorrhage. This is particularly problematic for preterm neonates as they are at higher risk of neurological injury. It has, though, advantage of shorter timeframe allowing for effective resuscitation of preterm neonates to start as soon as possible. Thus, with countering advantages and disadvantages, the practice has not been adopted at most places. The authors planned to conduct a randomized clinical trail to compare the efficacy and safety of umbilical cord milking to deferred cord clamping in preterm infants less than 32 weeks gestation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deferred Cord Clamping | No intervention | –Neonate is held at the level of placenta (level of introitus (vaginal delivery ) and mother's thigh or operating table (C/S) and cord clamping is deferred for 60 seconds. |
| Umbilical cord milking | Experimental | Other: Umbilical cord milkingManually stripping 20cm of cord segment toward the umbilicus over a period of 2-3 seconds three times before cord clamping. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Preterm infants < 32 weeks gestation confirmed by first trimester US
Key exclusion criteria (6 listed)
- Any proven or suspected congenital or chromosomal abnormalities
- Placenta previa or abruption
- Cord prolapse
- Known Rh sensitization
- Fetal hydrops
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 |
|---|---|---|
| Umbilical cord milkingMilking of the umbilical cord at delivery | Other | Umbilical cord milking |
Primary outcome
Intraventricular haemorrhage
Time frame: twenty eight days
Any IVH diagnosed by cranial ultrasound
20 secondary outcomes
Need for resuscitation
Time frame: one hour
Apgar score at one minute
Time frame: one minute after delivery
Apgar score at 5 minutes
Time frame: 5 minutes after delivery
The need for blood transfusion during hospital stay
Time frame: one month
Venous Hgb
Time frame: 2 days
Venous hematocrit
Time frame: 2 days
Bilirubin level
Time frame: 24 hours after birth
Maximum bilirubin level
Time frame: first week of life
Polycythemia
Time frame: first 48 hours after birth
Respiratory distress syndrome
Time frame: 48 hours after birth
Oxygen dependency
Time frame: first 28 days after birth and 36 weeks corrected age
Need for volume administration
Time frame: 24 hours after birth
Use of inotropes
Time frame: First 24 hours
Necrotizing enterocolitis
Time frame: one month
Mortality in hospital
Time frame: one month
Sepsis
Time frame: one month
Maternal mortality
Time frame: 2 weeks
Post partum hemorrhage
Time frame: one day
Maternal need for blood transfusion
Time frame: First 48 hours after delivery
Length of third stage
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2022.
- Individual participant dataSharing planned: Yes. We are planning to publish all the data that we will collect. If other researchers have specific questions about the data, we are willing to answer and share if needed.
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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.
Heidi Al-Wassia, MD principal investigator
King Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Umbilical cord milking in people with PreTerm Birth and Intraventricular Hemorrhage, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Aug 2022. 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 Saudi Arabia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heidi Al-Wassia (966544800441, halwassia@kau.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraventricular haemorrhage (time frame: twenty eight days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2022.