PrematurityNCT01523769
Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants
A study testing Umbilical Cord Milking in people with Prematurity, run by Eastern Virginia Medical School at 1 site in United States.
Trial summary
Delayed cord clamp of at least 30 seconds in neonates under 37 weeks has shown that these infants have higher circulating blood volume in the first 24 hours, less need for blood transfusions, and less incidence of intraventricular hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prematurity
- What is being tested?
- Umbilical Cord Milking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Nov 2011
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Singleton pregnancy
- Delivery anticipated between 24 and 28+6 weeks gestation
- There is enough time from admission to anticipated delivery to properly obtain consent from the patient
Who cannot join
- Multifetal gestation
- Antenatally diagnosed major congenital anomaly
- Known Rh sensitized pregnancy
- Hydrops fetalis (any etiology)
- Known positive maternal Parvovirus titers
- Elevated peak systolic velocity of the fetal Middle Cerebral Artery (MCA)
- Clinical suspicion of placental abruption at delivery due to excessive maternal bleeding or uterine hypertonicity
- Maternal age under 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Eastern Virginia Medical School
Norfolk, Virginia, 23507
About this study
Official title: The Efficacy of Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants Born Between 24 and 28 6/7 Weeks Gestation, a Randomized Controlled Trial.
Delayed cord clamp of at least 30 seconds in neonates under 37 weeks has shown that these infants have higher circulating blood volume in the first 24 hours, less need for blood transfusions, and less incidence of intraventricular hemorrhage. Delayed umbilical cord clamping has also been shown to increase the initial hematocrit and decrease the need for red blood cell (RBC) transfusions compared with no intervention in infants born between 27 and 33 weeks' gestation. However, a delay in cord clamping of 30-45 seconds may theoretically interfere with neonatal resuscitation. There have been few studies that addressed the active milking of the cord and its effect on neonatal resuscitation. Active milking of the umbilical cord towards the baby prior to clamping (rather than passive) should take less than 5 seconds to perform and should not interfere with neonatal resuscitation. Umbilical cord milking, as an alternative to delayed cord clamping, has been shown to increase the circulatory blood volume expressed as the hemoglobin value. Active milking of the cord prior to clamping, however, is not considered standard of care and only 1 Japanese randomized control study has reported that umbilical cord milking reduces the need for RBC transfusions, thus reducing the number of infants requiring a RBC transfusion as compared with control conditions. Our study aims to test the hypothesis that active milking of the umbilical cord will reduce the need for transfusion in preterm infants.
Read the detailed description
The proposed design is a randomized controlled trial. Pregnant women at risk for delivering a singleton preterm infant between 24 and 28 weeks gestation will be randomized prior to delivery into one of two treatment arms. Common reasons for needing to be delivered at this early gestational age include but are not limited to: preterm labor not responding to tocolytic medications, incompetent cervix with cervical dilation and no contractions, clinical chorioamnionitis requiring delivery for maternal/fetal benefit, severe preeclampsia, severe growth restriction with a non-reassuring fetal heart rate tracing. The first arm will include active milking of the umbilical cord toward the neonate's umbilicus prior to cord clamping at delivery while the second arm will not include this intervention and will have their respective cord immediately clamped in the usual fashion post delivery (control).
- Conditions
- Prematurity
- Being tested
- Umbilical Cord Milking
- Keywords
- prematurity, umbilical cord milking, delayed cord clamping, neonatal transfusion
- 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 MilkingProcedure or surgery
Also called Umbilical Cord Milking, autotransfusion
Approximately 10 cm of umbilical cord was milked toward the baby immediately following delivery. (The blood remaining in the umbilical cord after delivery is squeezed in the direction from the placenta (remaining inside the uterus) toward the newborn baby.)
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control group, the cord was not milked |
| Umbilical Cord Milking | Experimental | Approximately 10 cm of umbilical cord was milked toward the baby immediately following delivery Receives: Procedure: Umbilical Cord Milking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red blood cell transfusion
need for packed red blood cell transfusion in the first 28 days of neonatal life
Measured: 28 days
Secondary outcomes (19)
Volume of blood transfusion
total volume of packed RBC's transfused in first 28 days of neonatal life
Measured: 28 days
Intraventricular Hemorrhage
diagnosis of IVH in first 28 days of neonatal life
Measured: 28 days
Days until transfusion
number of days until first RBC transfusion in first 28 days of life
Measured: 28 days
Respiratory Distress Syndrome
diagnosis of RDS in first 28 days of neonatal life
Measured: 28 days
Retinopathy of Prematurity
diagnosis of ROP in first 28 days of neonatal life
Measured: 28 days
Chronic Lung Disease
diagnosis of CLD in first 28 days of neonatal life
Measured: 28 days
Sepsis
diagnosis of sepsis in first 28 days of neonatal life
Measured: 28 days
Necrotizing Enterocolitis
diagnosis of nec in first 28 days of neonatal life
Measured: 28 days
Apgar scores
1, 5, and 10 minute Apgars scores
Measured: 10 minutes
cord PH
umbilical cord pH immediately after delivery
Measured: 1 hour
Neonatal resuscitation
Neonatal Resuscitation measures immediately after birth, including intubation, surfactant administration, stimulation, compressions, epinephrine
Measured: 1 hour
Initial Hemoglobin/Hematocrit
Initial neonatal H/H
Measured: 1 day
Initial blood pressure
Initial neonatal blood pressure
Measured: 1 day
Neonatal jaundice
Need for bili lights to treat neonatal jaundice, maximum total bilirubin, number of days of bili lights
Measured: 28 days
Neonatal death
Incidence of neonatal death in the first 28 days of life, age of neonate at death
Measured: 28 days
Length of admission
Length of neonatal admission (up to 28 days)
Measured: 28 days
Length of intubation
Length of need for neonatal intubation in first 28 days of life
Measured: 28 days
Periventricular Leukomalacia
diagnosis of PVL in first 28 days of neonatal life
Measured: 28 days
Hyperkalemia
diagnosis of Hyperkalemia in first 28 days of neonatal life
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startSep 2009
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margarita deVeciana, MD, Principal investigator, Eastern Virginia Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523769
- Sponsor's protocol ID
- EasternVMC
- Status last verified
- Jan 2012
- First submitted
- 16 Dec 2011
- Last updated
- 1 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants Born Between 24 and 28 6/7 Weeks Gestation, a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01523769
- Acronym / sponsor ID
- EasternVMC
- Conditions
- Prematurity
- Keywords
- prematurity, umbilical cord milking, delayed cord clamping, neonatal transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Feb 2012 (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.
Delayed cord clamp of at least 30 seconds in neonates under 37 weeks has shown that these infants have higher circulating blood volume in the first 24 hours, less need for blood transfusions, and less incidence of intraventricular hemorrhage. Delayed umbilical cord clamping has also been shown to increase the initial hematocrit and decrease the need for red blood cell (RBC) transfusions compared with no intervention in infants born between 27 and 33 weeks' gestation. However, a delay in cord clamping of 30-45 seconds may theoretically interfere with neonatal resuscitation. There have been few studies that addressed the active milking of the cord and its effect on neonatal resuscitation. Active milking of the umbilical cord towards the baby prior to clamping (rather than passive) should take less than 5 seconds to perform and should not interfere with neonatal resuscitation. Umbilical cord milking, as an alternative to delayed cord clamping, has been shown to increase the circulatory blood volume expressed as the hemoglobin value. Active milking of the cord prior to clamping, however, is not considered standard of care and only 1 Japanese randomized control study has reported that umbilical cord milking reduces the need for RBC transfusions, thus reducing the number of infants requiring a RBC transfusion as compared with control conditions. Our study aims to test the hypothesis that active milking of the umbilical cord will reduce the need for transfusion in preterm infants.
Detailed description
The proposed design is a randomized controlled trial. Pregnant women at risk for delivering a singleton preterm infant between 24 and 28 weeks gestation will be randomized prior to delivery into one of two treatment arms. Common reasons for needing to be delivered at this early gestational age include but are not limited to: preterm labor not responding to tocolytic medications, incompetent cervix with cervical dilation and no contractions, clinical chorioamnionitis requiring delivery for maternal/fetal benefit, severe preeclampsia, severe growth restriction with a non-reassuring fetal heart rate tracing. The first arm will include active milking of the umbilical cord toward the neonate's umbilicus prior to cord clamping at delivery while the second arm will not include this intervention and will have their respective cord immediately clamped in the usual fashion post delivery (control).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control group, the cord was not milked |
| Umbilical Cord Milking | Experimental | Procedure: Umbilical Cord MilkingApproximately 10 cm of umbilical cord was milked toward the baby immediately following delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Singleton pregnancy
- Delivery anticipated between 24 and 28+6 weeks gestation
- There is enough time from admission to anticipated delivery to properly obtain consent from the patient
Key exclusion criteria (8 listed)
- Multifetal gestation
- Antenatally diagnosed major congenital anomaly
- Known Rh sensitized pregnancy
- Hydrops fetalis (any etiology)
- Known positive maternal Parvovirus titers
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 MilkingAlso: Umbilical Cord Milking, autotransfusionApproximately 10 cm of umbilical cord was milked toward the baby immediately following delivery. (The blood remaining in the umbilical cord after delivery is squeezed in the direction from the placenta (remaining inside the uterus) toward the newborn baby.) | Procedure or surgery | Umbilical Cord Milking |
Primary outcome
Red blood cell transfusion
Time frame: 28 days
need for packed red blood cell transfusion in the first 28 days of neonatal life
19 secondary outcomes
Volume of blood transfusion
Time frame: 28 days
Intraventricular Hemorrhage
Time frame: 28 days
Days until transfusion
Time frame: 28 days
Respiratory Distress Syndrome
Time frame: 28 days
Retinopathy of Prematurity
Time frame: 28 days
Chronic Lung Disease
Time frame: 28 days
Sepsis
Time frame: 28 days
Necrotizing Enterocolitis
Time frame: 28 days
Apgar scores
Time frame: 10 minutes
cord PH
Time frame: 1 hour
Neonatal resuscitation
Time frame: 1 hour
Initial Hemoglobin/Hematocrit
Time frame: 1 day
Initial blood pressure
Time frame: 1 day
Neonatal jaundice
Time frame: 28 days
Neonatal death
Time frame: 28 days
Length of admission
Time frame: 28 days
Length of intubation
Time frame: 28 days
Periventricular Leukomalacia
Time frame: 28 days
Hyperkalemia
Time frame: 28 days
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 1 Feb 2012.
Related trials for Prematurity
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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.
Margarita deVeciana, MD principal investigator
Eastern Virginia Medical School
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 Prematurity, run by Eastern Virginia Medical School at 1 site in United States.
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 3 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 1 Feb 2012. 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 United States. 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?
Red blood cell transfusion (time frame: 28 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 1 Feb 2012.