Premature BirthNCT01393834
Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate
A study testing Delayed cord clamping and Milking of the cord in people with Premature Birth, run by Medstar Health Research Institute.
Trial summary
This study is being done to evaluate if delaying cord clamping or milking the umbilical cord of the preterm infant has health benefits for the baby. Timing of clamping of the cord varies among doctors, but there is information that shows that delaying clamping of the umbilical cord in premature infants may reduce the… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Premature Birth
- What is being tested?
- Delayed cord clamping and Milking of the cord
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Dec 2011to Jan 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Singleton or multiples pregnancies in patients admitted for medically indicated delivery or in advanced spontaneous preterm labor with imminent delivery at 24 0/7 - 28 6/7 weeks gestation
- Women ages 18 and older
Who cannot join
- Planned vaginal breech delivery
- Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery)
- Fetal death in utero
- Red cell isoimmunization
- Patients who are incapable of informed consent (unconscious, severely ill, mentally handicapped), or are unwilling to undergo randomization
- Placenta previa or other known abnormal placentation (e.g. placenta accreta)
About this study
Official title: Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate - a Randomized, Controlled Trial
This study is being done to evaluate if delaying cord clamping or milking the umbilical cord of the preterm infant has health benefits for the baby. Timing of clamping of the cord varies among doctors, but there is information that shows that delaying clamping of the umbilical cord in premature infants may reduce the rate of the baby needing a blood transfusion, decrease the risk of infection and bleeding in the head.
- Conditions
- Premature Birth
- Being tested
- Delayed cord clamping, Milking of the cord
- Keywords
- Delayed cord clamping, Umbilical cord, Preterm, 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.
Delayed cord clampingProcedure or surgery
Delay cord clamping for 30 seconds after birth
Milking of the cordProcedure or surgery
Milking of the cord 4 times in 10 seconds
| Study group | Role | What they receive |
|---|---|---|
| Delayed cord clamping | Experimental | Delayed cord clamping for 30 seconds Receives: Procedure: Delayed cord clamping |
| Milking of the cord | Experimental | Milking of the cord 4 times in 10 seconds Receives: Procedure: Milking of the cord |
| Immediate cord clamping | No intervention | Immediate cord clamping after delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Neonatal Event
composite of bronchopulmonary dysplasia (BPD), necrotising eneterocolitis (NEC), grade 3 or 4 intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL), or death prior to discharge home
Measured: up to 24 weeks after birth
Secondary outcomes (25)
Maternal estimated blood loss
Estimated blood loss at delivery
Measured: up to 1 hour after delivery
Any grade intraventricular hemorrhage
Measured: up to 24 weeks after birth
Severe intraventricular hemorrhage (grade 3 or 4)
Measured: up to 24 weeks after birth
Periventricular leukomalacia
Measured: up to 24 weeks after birth
Bronchopulmonary dysplasia
Measured: up to 24 weeks after birth
Peak transcutaneous and/or serum bilirubin concentrations
Measured: up to 24 weeks after birth
Phototherapy
Requirement and length of phototherapy
Measured: up to 24 weeks after birth
Ionotropic support
Requirement and length of ionotropic support
Measured: up to 24 weeks after birth
Neonatal intesive care unit (NICU) length of stay
Measured: up to 24 weeks after birth
Sepsis
Measured: up to 24 weeks after birth
Necrotizing enterocolitis
Measured: up to 24 weeks after birth
Respiratory distress syndrome
Measured: up to 24 weeks after birth
Number of blood transfusions while in the neonatal intensive care unit
Measured: up to 24 weeks after birth
Ventilator time
Measured: up to 24 weeks after birth
Apgar score <7 at 5 minutes
Measured: at 5 minutes after birth
Umbilical cord pH < 7.0
Measured: up to 30 minutes after birth
Blood pressure on admission to neonatal intensive care unit
Measured: at 30 minutes after birth
Polycythemia
Measured: up to 24 hours of life
Hematocrit on admission to neonatal intensive care unit
Measured: up to 4 hours after birth
Neonatal death
Measured: up to 24 weeks of life
Length of 3rd stage of labor
Time period between delivery of the baby and delivery of the placenta
Measured: up to 1 hour after birth
Use of uterotonic agents
Measured: up to 1 hour after birth
Maternal blood transfusion
Measured: up to 5 days after delivery
Manual removal of placenta
Measured: up to 1 hour after birth
Operating time for cesarean delivery
Measured: up to 3 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startDec 2011
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: difficulty with enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rita W Driggers, MD, Principal investigator, Washington Hospital Center, Georgetown University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393834
- Sponsor's protocol ID
- 2011-053
- Status last verified
- Feb 2013
- First submitted
- 1 Jun 2011
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Umbilical Cord Clamping Versus Cord Milking in Preterm Neonate - a Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01393834
- Acronym / sponsor ID
- 2011-053
- Conditions
- Premature Birth
- Keywords
- Delayed cord clamping, Umbilical cord, Preterm, Cord milking
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty with enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 13 Jul 2011 (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.
This study is being done to evaluate if delaying cord clamping or milking the umbilical cord of the preterm infant has health benefits for the baby. Timing of clamping of the cord varies among doctors, but there is information that shows that delaying clamping of the umbilical cord in premature infants may reduce the rate of the baby needing a blood transfusion, decrease the risk of infection and bleeding in the head.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Delayed cord clamping | Experimental | Procedure: Delayed cord clampingDelayed cord clamping for 30 seconds |
| Milking of the cord | Experimental | Procedure: Milking of the cordMilking of the cord 4 times in 10 seconds |
| Immediate cord clamping | No intervention | –Immediate cord clamping after delivery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Singleton or multiples pregnancies in patients admitted for medically indicated delivery or in advanced spontaneous preterm labor with imminent delivery at 24 0/7 - 28 6/7 weeks gestation
- Women ages 18 and older
Key exclusion criteria (6 listed)
- Planned vaginal breech delivery
- Major fetal abnormalities (defined as those that are lethal or require prenatal or postnatal surgery)
- Fetal death in utero
- Red cell isoimmunization
- Patients who are incapable of informed consent (unconscious, severely ill, mentally handicapped), or are unwilling to undergo randomization
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 clampingDelay cord clamping for 30 seconds after birth | Procedure or surgery | Delayed cord clamping |
| Milking of the cordMilking of the cord 4 times in 10 seconds | Procedure or surgery | Milking of the cord |
Primary outcome
Adverse Neonatal Event
Time frame: up to 24 weeks after birth
composite of bronchopulmonary dysplasia (BPD), necrotising eneterocolitis (NEC), grade 3 or 4 intraventricular hemorrhage (IVH) or periventricular leukomalacia (PVL), or death prior to discharge home
25 secondary outcomes
Maternal estimated blood loss
Time frame: up to 1 hour after delivery
Any grade intraventricular hemorrhage
Time frame: up to 24 weeks after birth
Severe intraventricular hemorrhage (grade 3 or 4)
Time frame: up to 24 weeks after birth
Periventricular leukomalacia
Time frame: up to 24 weeks after birth
Bronchopulmonary dysplasia
Time frame: up to 24 weeks after birth
Peak transcutaneous and/or serum bilirubin concentrations
Time frame: up to 24 weeks after birth
Phototherapy
Time frame: up to 24 weeks after birth
Ionotropic support
Time frame: up to 24 weeks after birth
Neonatal intesive care unit (NICU) length of stay
Time frame: up to 24 weeks after birth
Sepsis
Time frame: up to 24 weeks after birth
Necrotizing enterocolitis
Time frame: up to 24 weeks after birth
Respiratory distress syndrome
Time frame: up to 24 weeks after birth
Number of blood transfusions while in the neonatal intensive care unit
Time frame: up to 24 weeks after birth
Ventilator time
Time frame: up to 24 weeks after birth
Apgar score <7 at 5 minutes
Time frame: at 5 minutes after birth
Umbilical cord pH < 7.0
Time frame: up to 30 minutes after birth
Blood pressure on admission to neonatal intensive care unit
Time frame: at 30 minutes after birth
Polycythemia
Time frame: up to 24 hours of life
Hematocrit on admission to neonatal intensive care unit
Time frame: up to 4 hours after birth
Neonatal death
Time frame: up to 24 weeks of life
Length of 3rd stage of labor
Time frame: up to 1 hour after birth
Use of uterotonic agents
Time frame: up to 1 hour after birth
Maternal blood transfusion
Time frame: up to 5 days after delivery
Manual removal of placenta
Time frame: up to 1 hour after birth
Operating time for cesarean delivery
Time frame: up to 3 hours after birth
Results and safety
The study was stopped early (reason given: difficulty with enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2013.
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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.
Rita W Driggers, MD principal investigator
Washington Hospital Center, Georgetown University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Delayed cord clamping and Milking of the cord in people with Premature Birth, run by Medstar Health Research Institute.
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 2 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: stopped early, as of the sponsor's last update on 22 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: difficulty with enrollment). Results are not available in the source record.
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?
Adverse Neonatal Event (time frame: up to 24 weeks after birth). 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 22 Feb 2013.