AnemiaEarly Phase 1NCT01630993
Milking the Umbilical Cord at Term Cesarean Birth
A Early Phase 1 study testing Umbilical Cord Milking in people with Anemia, run by University of Rhode Island at 1 site in United States.
Trial summary
The purpose of this pilot study is to determine if umbilical cord milking at the time of scheduled cesarean section effects the hemoglobin and hematocrit levels of full-term infants as determined by hemoglobin and hematocrit levels at 36-48 hours of life. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- Umbilical Cord Milking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Dec 2009
- Phase
- Early Phase 1
- 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 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women at full term gestation (37-41 weeks) with:
- Uncomplicated, singleton pregnancy
- English speaking
- Planning an elective Cesarean Section
- Not in labor
Who cannot join
- Major medical or obstetrical complications
- Women who smoke
- Intrauterine growth restriction
- Serious congenital anomalies
Trial locations and contacts
1 site in 1 country.
United States1 site
Women & Infants Hospital
Providence, Rhode Island, 02905
About this study
Official title: Milking the Umbilical Cord at Term Cesarean Birth: Effect on Hemoglobin Levels in the First 48 Hours of Life
The purpose of this pilot study is to determine if umbilical cord milking at the time of scheduled cesarean section effects the hemoglobin and hematocrit levels of full-term infants as determined by hemoglobin and hematocrit levels at 36-48 hours of life. This study will help to establish the feasibility of umbilical cord milking as an alternative to delayed clamping at the time of planned cesarean section.
Read the detailed description
New evidence suggests the practice of immediate clamping and cutting of the umbilical cord at birth may contribute to anemia in infancy. Immediate clamping can deprive a full term infant of 60 to 100 ml of whole blood representing 30 to 50 mg/kg of iron. The "low tech-low cost" intervention of delayed cord clamping can reduce anemia in infancy by enhancing placental-infant transfusion at birth. The risk of maternal bleeding makes a delay in cord clamping at the time of cesarean section challenging. In the United States (US), immediate clamping and cutting of the umbilical cord is the usual practice at the time of cesarean section. Milking of the umbilical cord may offer an alternative to delayed cord clamping for the prevention of anemia in infancy when time and speed are critical factors at the time of cesarean section. Although some obstetrical and pediatric providers fear adverse outcomes from delayed cord clamping or umbilical cord milking such as polycythemia or jaundice, the most recent clinical trials fail to support these fears.
In spite of iron supplementation and iron fortified formula and food, iron deficiency in infants and toddlers remains a significant public health problem in the US. Poor iron stores in the first year of life can lead to iron deficiency which has the potential to cause harm to the developing brain.
The number of births by cesarean section is on the rise in this country. According to the latest US birth data reported by the National Center for Health Statistics, the cesarean section rate is now above 32%, over a 50% increase since 1996. Immediate cord clamping is routine practice at the time of cesarean section in the US. Consequently over 1.4 million babies annually will have their umbilical cords cut immediately at the time of birth. This routine practice interferes in placental transfusion and results in less blood volume and red blood cells and increases anemia at birth and lowers total body iron stores in the newborn at six months. The potential effect of immediate cord clamping at cesarean section is enormous on the public health of infants in this country. However the association between cord clamping time and infant well-being is not generally recognized by clinicians.
Delaying the clamping and cutting of the cord for just two minutes is known to offer benefit and can improve the iron stores of term newborns extending into at least the first six months of life. Although there is benefit for the baby, a two minute delay is not feasible for the mother at time of cesarean section. However, milking of the umbilical cord at the time of cesarean section may be a viable alternative to delayed cord clamping and may prevent anemia and infant iron deficiency. Most of the available literature on umbilical cord milking was written over 50 years ago. Even so, these studies support the technique as safe for term infants resulting in higher neonatal hemoglobin and hematocrit levels. One recent study found cord milking was beneficial and did not cause harm in very low birth weight preterm infants.
This study will help to establish the feasibility of using umbilical cord milking as an alternative to delayed cord clamping at the time of cesarean section. Umbilical cord milking will be examined as a selective intervention to accelerate placental transfusion when delayed clamping is not ideal. It has the potential to prevent anemia and iron deficiency in infancy in full-term infants born by cesarean section.
- Conditions
- Anemia
- Being tested
- Umbilical Cord Milking
- Keywords
- umbilical cord milking, umbilical cord stripping, umbilical cord clamping, placental transfusion, placental residual blood volume
- Medical subject headings
- Anemia, Fetofetal Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical Cord MilkingOther
Also called Umbilical Cord Stripping
At birth, the infant will be held below the level of the placenta and umbilical cord will be milked 5 times after birth and before clamping the cord.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Milking | Experimental | At birth, the infant will be held below the level of the placenta and umbilical cord will be milked 5 times after birth and before clamping the cord. Receives: Other: Umbilical Cord Milking |
| Immediate Cord Clamping | No intervention | At birth, the infant will be held at the level of the placenta and umbilical cord will be clamped within 10 seconds (routine practice). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Newborn Hemoglobin and Hematocrit levels
At 36-48 hours, term infants (born by planned cesarean section) exposed to umbilical cord milking will have higher hemoglobin and hematocrit levels compared to infants exposed to immediate cord clamping
Measured: 36-48 hours of life
Secondary outcomes (1)
Placental Residual Blood Volume
Term infants (born by planned cesarean section) exposed to umbilical cord milking will have lower placental residual blood volume compared to infants exposed to immediate cord clamping
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startMay 2008
- Primary completionApr 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Debra Erickson-Owens, University of Rhode Island
- Investigators
- Debra Erickson-Owens, PhD, CNM, Principal investigator, University of Rhode IslandJudith Mercer, PhD, CNM, Principal investigator, University of Rhode Island and Women & Infants Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630993
- Sponsor's protocol ID
- HU0708-113M
- Status last verified
- Oct 2015
- First submitted
- 26 Jun 2012
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Erickson-Owens DA, Mercer JS, Oh W. Umbilical cord milking in term infants delivered by cesarean section: a randomized controlled trial. J Perinatol. 2012 Aug;32(8):580-4. doi: 10.1038/jp.2011.159. Epub 2011 Nov 17.
PubMed 22094494
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Milking the Umbilical Cord at Term Cesarean Birth: Effect on Hemoglobin Levels in the First 48 Hours of Life
- ClinicalTrials.gov ID
- NCT01630993
- Acronym / sponsor ID
- HU0708-113M
- Conditions
- Anemia
- Keywords
- umbilical cord milking, umbilical cord stripping, umbilical cord clamping, placental transfusion, placental residual blood volume
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 28 Jun 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.
The purpose of this pilot study is to determine if umbilical cord milking at the time of scheduled cesarean section effects the hemoglobin and hematocrit levels of full-term infants as determined by hemoglobin and hematocrit levels at 36-48 hours of life. This study will help to establish the feasibility of umbilical cord milking as an alternative to delayed clamping at the time of planned cesarean section.
Detailed description
New evidence suggests the practice of immediate clamping and cutting of the umbilical cord at birth may contribute to anemia in infancy. Immediate clamping can deprive a full term infant of 60 to 100 ml of whole blood representing 30 to 50 mg/kg of iron. The "low tech-low cost" intervention of delayed cord clamping can reduce anemia in infancy by enhancing placental-infant transfusion at birth. The risk of maternal bleeding makes a delay in cord clamping at the time of cesarean section challenging. In the United States (US), immediate clamping and cutting of the umbilical cord is the usual practice at the time of cesarean section. Milking of the umbilical cord may offer an alternative to delayed cord clamping for the prevention of anemia in infancy when time and speed are critical factors at the time of cesarean section. Although some obstetrical and pediatric providers fear adverse outcomes from delayed cord clamping or umbilical cord milking such as polycythemia or jaundice, the most recent clinical trials fail to support these fears.
In spite of iron supplementation and iron fortified formula and food, iron deficiency in infants and toddlers remains a significant public health problem in the US. Poor iron stores in the first year of life can lead to iron deficiency which has the potential to cause harm to the developing brain.
The number of births by cesarean section is on the rise in this country. According to the latest US birth data reported by the National Center for Health Statistics, the cesarean section rate is now above 32%, over a 50% increase since 1996. Immediate cord clamping is routine practice at the time of cesarean section in the US. Consequently over 1.4 million babies annually will have their umbilical cords cut immediately at the time of birth. This routine practice interferes in placental transfusion and results in less blood volume and red blood cells and increases anemia at birth and lowers total body iron stores in the newborn at six months. The potential effect of immediate cord clamping at cesarean section is enormous on the public health of infants in this country. However the association between cord clamping time and infant well-being is not generally recognized by clinicians.
Delaying the clamping and cutting of the cord for just two minutes is known to offer benefit and can improve the iron stores of term newborns extending into at least the first six months of life. Although there is benefit for the baby, a two minute delay is not feasible for the mother at time of cesarean section. However, milking of the umbilical cord at the time of cesarean section may be a viable alternative to delayed cord clamping and may prevent anemia and infant iron deficiency. Most of the available literature on umbilical cord milking was written over 50 years ago. Even so, these studies support the technique as safe for term infants resulting in higher neonatal hemoglobin and hematocrit levels. One recent study found cord milking was beneficial and did not cause harm in very low birth weight preterm infants.
This study will help to establish the feasibility of using umbilical cord milking as an alternative to delayed cord clamping at the time of cesarean section. Umbilical cord milking will be examined as a selective intervention to accelerate placental transfusion when delayed clamping is not ideal. It has the potential to prevent anemia and iron deficiency in infancy in full-term infants born by cesarean section.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Milking | Experimental | Other: Umbilical Cord MilkingAt birth, the infant will be held below the level of the placenta and umbilical cord will be milked 5 times after birth and before clamping the cord. |
| Immediate Cord Clamping | No intervention | –At birth, the infant will be held at the level of the placenta and umbilical cord will be clamped within 10 seconds (routine practice). |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women at full term gestation (37-41 weeks) with:
- Uncomplicated, singleton pregnancy
- English speaking
- Planning an elective Cesarean Section
- Not in labor
Key exclusion criteria (4 listed)
- Major medical or obstetrical complications
- Women who smoke
- Intrauterine growth restriction
- Serious congenital anomalies
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 StrippingAt birth, the infant will be held below the level of the placenta and umbilical cord will be milked 5 times after birth and before clamping the cord. | Other | Umbilical Cord Milking |
Primary outcome
Newborn Hemoglobin and Hematocrit levels
Time frame: 36-48 hours of life
At 36-48 hours, term infants (born by planned cesarean section) exposed to umbilical cord milking will have higher hemoglobin and hematocrit levels compared to infants exposed to immediate cord clamping
1 secondary outcome
Placental Residual Blood Volume
Time frame: At birth
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 5 Oct 2015.
- Results publication: PubMed 22094494Erickson-Owens DA, Mercer JS, Oh W. Umbilical cord milking in term infants delivered by cesarean section: a randomized controlled trial. J Perinatol. 2012 Aug;32(8):580-4. doi: 10.1038/jp.2011.159. Epub 2011 Nov 17.
Related trials for Anemia
RecruitingPhase 1/2
The Safety and Efficacy of Daratumumab in Patients With Refractory Aplastic Anemia
Aplastic Anemia, Refractory
Active, not recruitingPhase 1
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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.
Debra Erickson-Owens, PhD, CNM principal investigator
University of Rhode Island
Judith Mercer, PhD, CNM principal investigator
University of Rhode Island and Women & Infants Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Umbilical Cord Milking in people with Anemia, run by University of Rhode Island 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 5 inclusion and 4 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 5 Oct 2015. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Newborn Hemoglobin and Hematocrit levels (time frame: 36-48 hours of life). 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 NCT01630993, which also lists 1 linked publication.
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 5 Oct 2015.