AnemiaNCT01924572
Placental Transfusion in Term Infants: A Pilot Study
A study testing cord clamping at 2 minutes, cord clamping at 5 minutes and cord milking in people with Anemia, run by University of Rhode Island at 1 site in United States.
Trial summary
The proposed study is a pilot prospective controlled trial to measure the blood volume left in the placenta after varying cord clamping times when the infant is placed skin-to-skin on the maternal abdomen. Delaying cord clamping has been shown to decrease anemia in infants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anemia
- What is being tested?
- cord clamping at 2 minutes, cord clamping at 5 minutes and cord milking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to May 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion Criteria: Women with normal pregnancy and presented at the labor room at 38-416/7 weeks for vaginal delivery; Intention to breast feed the babies; Consent for a follow up at 2 weeks of age
Exclusion Criteria: Abnormal pregnancy: Gestational or pre-existing diabetes, smoking and substance abuse, pre-eclampsia, fetal abnormality
Trial locations and contacts
1 site in 1 country.
United States1 site
Women & Infants Hospital
Providence, Rhode Island, 02905
About this study
Official title: Placental Transfusion in Term Infants Placed Skin-to-Skin: A Pilot Controlled Trial
The proposed study is a pilot prospective controlled trial to measure the blood volume left in the placenta after varying cord clamping times when the infant is placed skin-to-skin on the maternal abdomen. Delaying cord clamping has been shown to decrease anemia in infants. However, the best way to get the most blood to the baby is not known. The practice of cord clamping at birth is not the same among doctors and midwives and we do not know the effect of putting he baby on the mother's abdomen.
Read the detailed description
The proposed study is a pilot prospective controlled trial to measure the placental residual blood volume after varying cord clamping protocols when the infants are placed skin-to-skin on the maternal abdomen. The study assessed compliance of the providers with the different protocols. Placental transfusion (PT) has been shown to increase infant body iron stores at 6 months of age without increasing adverse outcomes. However, the optimal protocol to achieve adequate placental transfusion is not known. The practice of cord clamping at birth is not uniform among obstetrical providers because adequate evidence to support early or late cord clamping has been lacking.
Women were eligible to enroll in the study if they had no pregnancy complications, did not smoke, planned to breastfeed, and planned to deliver vaginally between 37 and 416/7 weeks. Women were enrolled prenatally on the labor and delivery unit. At birth, women were assigned to one of four cord clamping/milking groups. A cohort of infants with immediate cord clamping serves as reference group. Infants had blood samples drawn with the routine newborn screening blood samples done at 36 to 48 hours. Information on infant health and feeding was completed through an in-hospital visit to the mother and by home visit at two weeks of age. The primary outcome measures were placental residual blood volume and compliance with the various assigned cord clamping protocols. It was expected that infants with delayed cord clamping or cord milking would have less placental residual blood volume and that most providers would comply with the various random assignments.
- Conditions
- Anemia
- Being tested
- cord clamping at 2 minutes, cord clamping at 5 minutes, cord milking
- Keywords
- umbilical cord clamping, Placental residual blood volume, hematocrit, hemoglobin, bilirubin
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cord clamping at 2 minutesProcedure or surgery
cord clamping at 5 minutesProcedure or surgery
cord milkingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Immediate cord clamping | No intervention | provider clamps and cuts the cord within 10 seconds after birth |
| cord clamping at 2 minutes | Experimental | Provider places infant on maternal abdomen and cuts cord at 2 minutes after birth Receives: Procedure: cord clamping at 2 minutes |
| cord clamping at 5 minutes | Experimental | Provider places the infant on maternal abdomen and clamps and cuts cord at 5 minutes Receives: Procedure: cord clamping at 5 minutes |
| cord milking | Experimental | provider milks the cord 5 times from placenta to infant Receives: Procedure: cord milking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placental Residual Blood volume
Blood remaining in the placenta after cord clamping measured by drainage
Measured: obtained immediately after birth
Secondary outcomes (1)
Infant hematocrit and hemoglobin
Capillary hematocrit and hemoglobin drawn when the genetic samples were drawn
Measured: at 36 to 48 hours of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startJul 2010
- Primary completionJan 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith S Mercer, University of Rhode Island
- Investigators
- Judith S Mercer, PhD, CNM, Principal investigator, University of Rhode IslandDebra A Erickson-owens, PhD, CNM, Study director, University of Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01924572
- Sponsor's protocol ID
- Term Pilot Study
- Status last verified
- Aug 2013
- First submitted
- 14 Aug 2013
- Last updated
- 16 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placental Transfusion in Term Infants Placed Skin-to-Skin: A Pilot Controlled Trial
- ClinicalTrials.gov ID
- NCT01924572
- Acronym / sponsor ID
- Term Pilot Study
- Conditions
- Anemia
- Keywords
- umbilical cord clamping, Placental residual blood volume, hematocrit, hemoglobin, bilirubin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Rhode IslandUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 Aug 2013 (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 proposed study is a pilot prospective controlled trial to measure the blood volume left in the placenta after varying cord clamping times when the infant is placed skin-to-skin on the maternal abdomen. Delaying cord clamping has been shown to decrease anemia in infants. However, the best way to get the most blood to the baby is not known. The practice of cord clamping at birth is not the same among doctors and midwives and we do not know the effect of putting he baby on the mother's abdomen.
Detailed description
The proposed study is a pilot prospective controlled trial to measure the placental residual blood volume after varying cord clamping protocols when the infants are placed skin-to-skin on the maternal abdomen. The study assessed compliance of the providers with the different protocols. Placental transfusion (PT) has been shown to increase infant body iron stores at 6 months of age without increasing adverse outcomes. However, the optimal protocol to achieve adequate placental transfusion is not known. The practice of cord clamping at birth is not uniform among obstetrical providers because adequate evidence to support early or late cord clamping has been lacking.
Women were eligible to enroll in the study if they had no pregnancy complications, did not smoke, planned to breastfeed, and planned to deliver vaginally between 37 and 416/7 weeks. Women were enrolled prenatally on the labor and delivery unit. At birth, women were assigned to one of four cord clamping/milking groups. A cohort of infants with immediate cord clamping serves as reference group. Infants had blood samples drawn with the routine newborn screening blood samples done at 36 to 48 hours. Information on infant health and feeding was completed through an in-hospital visit to the mother and by home visit at two weeks of age. The primary outcome measures were placental residual blood volume and compliance with the various assigned cord clamping protocols. It was expected that infants with delayed cord clamping or cord milking would have less placental residual blood volume and that most providers would comply with the various random assignments.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Immediate cord clamping | No intervention | –provider clamps and cuts the cord within 10 seconds after birth |
| cord clamping at 2 minutes | Experimental | Procedure: cord clamping at 2 minutesProvider places infant on maternal abdomen and cuts cord at 2 minutes after birth |
| cord clamping at 5 minutes | Experimental | Procedure: cord clamping at 5 minutesProvider places the infant on maternal abdomen and clamps and cuts cord at 5 minutes |
| cord milking | Experimental | Procedure: cord milkingprovider milks the cord 5 times from placenta to infant |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| cord clamping at 2 minutes | Procedure or surgery | cord clamping at 2 minutes |
| cord clamping at 5 minutes | Procedure or surgery | cord clamping at 5 minutes |
| cord milking | Procedure or surgery | cord milking |
Primary outcome
Placental Residual Blood volume
Time frame: obtained immediately after birth
Blood remaining in the placenta after cord clamping measured by drainage
1 secondary outcome
Infant hematocrit and hemoglobin
Time frame: at 36 to 48 hours of age
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 16 Aug 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.
Judith S Mercer, PhD, CNM principal investigator
University of Rhode Island
Debra A Erickson-owens, PhD, CNM study director
University of Rhode Island
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cord clamping at 2 minutes, cord clamping at 5 minutes and 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?
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 16 Aug 2013. 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?
Placental Residual Blood volume (time frame: obtained immediately 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 16 Aug 2013.