Anemia, Iron-DeficiencyNCT02892461
Effect of Umbilical Cord Milking on Iron Related Health Outcomes for Cesarean-Delivered Infants
A study testing Umbilical cord milking in people with Anemia, Iron-Deficiency, run by Peking University at 2 sites in China.
Trial summary
This study aims to determine whether umbilical cord milking can improve iron related health outcomes for cesarean-delivered infants. Half of participants will receive umbilical cord milking, while the other half will receive routine clinical treatment and care. Read more about this study
- Who is it for?
- Ages 20 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia, Iron-Deficiency
- 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
- 484 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2016to Apr 2019
- 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 20 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancy
- Full-term pregnancy (no less than 37 gestational weeks)
- Cesarean section before the labor starts or cesarean section after the labor starts but with cervix less than 3 cm
- Plan to take vaccines and receive routine child health care in the hospital where she gives birth
Who cannot join
- Maternal hypertensive disorder
- Gestational diabetes with macrosomia
- Gestational diabetes with polyhydramnios
- Maternal severe anemia with hemoglobin less than 70 g/L
- Maternal coagulation disorders
- Fetal growth restriction
Show all 11Show fewer
- Major congenital anomalies
- Hemolytic disease of the newborn or hydrops fetalis
- Short umbilical cord length (< 30 cm)
- Severe cord or placenta abnormalities such as cord prolapse, true knots, placental abruption and placenta previa
- Other conditions that are not suitable for the study judged by the doctors
Trial locations and contacts
2 sites in 1 country.
China2 sites
Hunan Provincial Maternal and Child Health Care Hospital
Changsha, Hunan, 410008
Liuyang Maternal and Child Health Care Hospital
Guankou, Hunan, 410399
About this study
Official title: Effect of Umbilical Cord Milking on Iron Related Health Outcomes for Cesarean-Delivered Infants: A Randomized Controlled Trial
This study aims to determine whether umbilical cord milking can improve iron related health outcomes for cesarean-delivered infants. Half of participants will receive umbilical cord milking, while the other half will receive routine clinical treatment and care.
Read the detailed description
In recent years, several professional organizations have recommended delayed cord clamping to improve placental transfusion for newborns born vaginally based on a series of randomized controlled studies. However, no similar recommendations are available for cesarean-delivered infants. Investigators found that cesarean-delivered infants were more vulnerable to iron deficiency and anemia compared with those born vaginally, suggesting that it is urgently needed to find a similar anemia prevention strategy for infants born by cesarean sections.
In this study, investigators aim to test whether umbilical cord milking (UCM), a potentially promising strategy for cesarean delivery, can improve iron related health outcomes for cesarean-delivered infants. A total of 450 term pregnant women who are planning to give births by cesarean sections will be enrolled from two hospitals in Hunan province and randomly assigned to either UCM group or control group. Infants will be followed up at 1, 6, 12, 18 months for the evaluation of the impact of UCM on iron deficiency, anemia, as well as growth and the developmental status of language and mental/behavioral outcomes.
- Conditions
- Anemia, Iron-Deficiency
- Being tested
- Umbilical cord milking
- Keywords
- Anemia, Iron-Deficiency, Cesarean Section, Umbilical Cord Milking, Randomized Controlled Trial
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord milkingProcedure or surgery
As same as that in arm descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical cord milking | Experimental | The cord will be cut at 25 cm from the umbilical stump within 30 seconds after the infant is taken out from the uterus and its blood will be milked to the infant gently and thoroughly in 30 seconds during resuscitation on the radiant warmer, and then the cord will be cut at 2 to 3 cm from the umbilical stump. Receives: Procedure: Umbilical cord milking |
| Routine clinical treatment and care | No intervention | The cord will be dealt with routine clinical method, which means it will be cut twice within 1minute after the infant is taken out from the uterus, the first cut is on the operating table, while the second cut is on the radiant warmer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in infant's serum ferritin (μg/L)
At birth (baseline)-2 ml umbilical cord blood, 6 and 12 months old-2 ml infant's venous blood for each measure.
Measured: At birth (baseline), 6 and 12 months after birth
Secondary outcomes (10)
Change in infant's erythrocyte counts (10^12/L)
At birth (baseline)-1 ml umbilical cord blood, 1 month old-20 μL infant's peripheral blood of finger, 6 and 12 months old-1 ml infants' venous blood for each measure.
Measured: At birth (baseline), 1, 6 and 12 months after birth
Change in infant's hemoglobin concentration (g/L)
A participant's erythrocyte counts and hemoglobin concentration are detected using the same blood sample.
Measured: At birth (baseline), 1, 6 and 12 months after birth
Change in infant's hematocrit (%)
A participant's erythrocyte counts, hemoglobin concentration and hematocrit are detected using the same blood sample.
Measured: At birth (baseline), 1, 6 and 12 months after birth
Change in infant's weight (kg)
Every infant's weight will be measured twice each time, but if the difference between the two measurement results is more than 0.1 kg, it will be measured for the third time.
Measured: At birth (baseline), 1, 6, 12 and 18 months after birth
Change in infant's height (cm)
Every infant's height will be measured twice each time, but if the difference between the two measurement results is more than 0.5 cm, it will be measured for the third time.
Measured: At birth (baseline), 1, 6, 12 and 18 months after birth
Infant's language development
The infant's development status of language will be assessed by the Language Developmental Survey (LDS).
Measured: 18 months old
Infant's mental/behavioral development
The infant's mental/behavioral development will be assessed by the Child Behavior Checklist (CBCL).
Measured: 18 months old
Change in infant's transcutaneous bilirubin concentration (mg/dL)
An infant's transcutaneous bilirubin concentration will be detected for five days after birth with time recorded. To ensure accuracy, each time it will be repeatedly detected for three times.
Measured: 1 (baseline), 2, 3, 4 and 5 days after birth
Number of infants with neonatal jaundice in the experimental group and the control group
At each follow-up visit (1, 6, 12 and 18 months after birth), parents will be asked whether their children suffer from jaundice up to then. If so, the doctor will ask them about the onset time, possible causes, treatment and prognosis of the disease.
Measured: Up to 18 months old
Number of infants with polycythemia in the experimental group and the control group
At each follow-up visit (1, 6, 12 and 18 months after birth), parents will be asked whether their children suffer from polycythemia up to then.
Measured: Up to 18 months old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Anemia, Iron-DeficiencyStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China, Hunan Provincial Maternal and Child Health Care Hospital, Liuyang Maternal and Child Health Care Hospital
- Responsible party
- Principal investigator, Jianmeng Liu, Peking University
- Investigators
- Jianmeng Liu, PhD, Study chair, Peking UniversityHongtian Li, PhD, Principal investigator, Peking UniversityYubo Zhou, PhD, Principal investigator, Peking UniversityQiyun Du, MD, Principal investigator, Hunan Provincial Maternal and Child Health Care HospitalShujin Zhou, B.S.Med, Principal investigator, Liuyang Maternal and Child Health Care Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892461
- Sponsor's protocol ID
- 81571517
- Status last verified
- Mar 2020
- First submitted
- 23 Aug 2016
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Li HT, Trasande L, Zhu LP, Ye RW, Zhou YB, Liu JM. Association of cesarean delivery with anemia in infants and children in 2 large longitudinal Chinese birth cohorts. Am J Clin Nutr. 2015 Mar;101(3):523-9. doi: 10.3945/ajcn.114.092585. Epub 2014 Dec 24.
PubMed 25733637McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.
PubMed 23843134Hutton EK, Hassan ES. Late vs early clamping of the umbilical cord in full-term neonates: systematic review and meta-analysis of controlled trials. JAMA. 2007 Mar 21;297(11):1241-52. doi: 10.1001/jama.297.11.1241.
PubMed 17374818Perlman JM, Wyllie J, Kattwinkel J, Atkins DL, Chameides L, Goldsmith JP, Guinsburg R, Hazinski MF, Morley C, Richmond S, Simon WM, Singhal N, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 11: Neonatal resuscitation: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2010 Oct 19;122(16 Suppl 2):S516-38. doi: 10.1161/CIRCULATIONAHA.110.971127. No abstract available.
PubMed 20956259Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Committee Opinion No.543: Timing of umbilical cord clamping after birth. Obstet Gynecol. 2012 Dec;120(6):1522-6. doi: 10.1097/01.AOG.0000423817.47165.48.
PubMed 23168790McCAUSLAND AM, HOLMES F, SCHUMANN WR. Management of cord and placental blood and its effect upon the newborn. Calif Med. 1949 Sep;71(3):190-6.
PubMed 18137215SIDDALL RS, CRISSEY RR, KNAPP WL. Effect on cesarean section babies of stripping or milking of the umbilical cords. Am J Obstet Gynecol. 1952 May;63(5):1059-64. doi: 10.1016/0002-9378(52)90546-2. No abstract available.
PubMed 14923706Daniel DG, Weerakkody AN. Neonatal prevention of iron deficiency. Blood can be transfused from cord clamped at placental end. BMJ. 1996 Apr 27;312(7038):1102-3. doi: 10.1136/bmj.312.7038.1102d. No abstract available.
PubMed 8616446Upadhyay A, Gothwal S, Parihar R, Garg A, Gupta A, Chawla D, Gulati IK. Effect of umbilical cord milking in term and near term infants: randomized control trial. Am J Obstet Gynecol. 2013 Feb;208(2):120.e1-6. doi: 10.1016/j.ajog.2012.10.884. Epub 2012 Oct 31.
PubMed 23123382Mercer JS, Erickson-Owens DA. Rethinking placental transfusion and cord clamping issues. J Perinat Neonatal Nurs. 2012 Jul-Sep;26(3):202-17; quiz 218-9. doi: 10.1097/JPN.0b013e31825d2d9a.
PubMed 22843002
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Umbilical Cord Milking on Iron Related Health Outcomes for Cesarean-Delivered Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02892461
- Acronym / sponsor ID
- 81571517
- Conditions
- Anemia, Iron-Deficiency
- Keywords
- Anemia, Iron-Deficiency, Cesarean Section, Umbilical Cord Milking, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China, Hunan Provincial Maternal and Child Health Care Hospital, Liuyang Maternal and Child Health Care Hospital
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 8 Sep 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.
This study aims to determine whether umbilical cord milking can improve iron related health outcomes for cesarean-delivered infants. Half of participants will receive umbilical cord milking, while the other half will receive routine clinical treatment and care.
Detailed description
In recent years, several professional organizations have recommended delayed cord clamping to improve placental transfusion for newborns born vaginally based on a series of randomized controlled studies. However, no similar recommendations are available for cesarean-delivered infants. Investigators found that cesarean-delivered infants were more vulnerable to iron deficiency and anemia compared with those born vaginally, suggesting that it is urgently needed to find a similar anemia prevention strategy for infants born by cesarean sections.
In this study, investigators aim to test whether umbilical cord milking (UCM), a potentially promising strategy for cesarean delivery, can improve iron related health outcomes for cesarean-delivered infants. A total of 450 term pregnant women who are planning to give births by cesarean sections will be enrolled from two hospitals in Hunan province and randomly assigned to either UCM group or control group. Infants will be followed up at 1, 6, 12, 18 months for the evaluation of the impact of UCM on iron deficiency, anemia, as well as growth and the developmental status of language and mental/behavioral outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical cord milking | Experimental | Procedure: Umbilical cord milkingThe cord will be cut at 25 cm from the umbilical stump within 30 seconds after the infant is taken out from the uterus and its blood will be milked to the infant gently and thoroughly in 30 seconds during resuscitation on the radiant warmer, and then the cord will be cut at 2 to 3 cm from the umbilical stump. |
| Routine clinical treatment and care | No intervention | –The cord will be dealt with routine clinical method, which means it will be cut twice within 1minute after the infant is taken out from the uterus, the first cut is on the operating table, while the second cut is on the radiant warmer. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Singleton pregnancy
- Full-term pregnancy (no less than 37 gestational weeks)
- Cesarean section before the labor starts or cesarean section after the labor starts but with cervix less than 3 cm
- Plan to take vaccines and receive routine child health care in the hospital where she gives birth
Key exclusion criteria (11 listed)
- Maternal hypertensive disorder
- Gestational diabetes with macrosomia
- Gestational diabetes with polyhydramnios
- Maternal severe anemia with hemoglobin less than 70 g/L
- Maternal coagulation disorders
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 milkingAs same as that in arm descriptions. | Procedure or surgery | Umbilical cord milking |
Primary outcome
Change in infant's serum ferritin (μg/L)
Time frame: At birth (baseline), 6 and 12 months after birth
At birth (baseline)-2 ml umbilical cord blood, 6 and 12 months old-2 ml infant's venous blood for each measure.
10 secondary outcomes
Change in infant's erythrocyte counts (10^12/L)
Time frame: At birth (baseline), 1, 6 and 12 months after birth
Change in infant's hemoglobin concentration (g/L)
Time frame: At birth (baseline), 1, 6 and 12 months after birth
Change in infant's hematocrit (%)
Time frame: At birth (baseline), 1, 6 and 12 months after birth
Change in infant's weight (kg)
Time frame: At birth (baseline), 1, 6, 12 and 18 months after birth
Change in infant's height (cm)
Time frame: At birth (baseline), 1, 6, 12 and 18 months after birth
Infant's language development
Time frame: 18 months old
Infant's mental/behavioral development
Time frame: 18 months old
Change in infant's transcutaneous bilirubin concentration (mg/dL)
Time frame: 1 (baseline), 2, 3, 4 and 5 days after birth
Number of infants with neonatal jaundice in the experimental group and the control group
Time frame: Up to 18 months old
Number of infants with polycythemia in the experimental group and the control group
Time frame: Up to 18 months old
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 17 Mar 2020.
- Background: PubMed 25733637Li HT, Trasande L, Zhu LP, Ye RW, Zhou YB, Liu JM. Association of cesarean delivery with anemia in infants and children in 2 large longitudinal Chinese birth cohorts. Am J Clin Nutr. 2015 Mar;101(3):523-9. doi: 10.3945/ajcn.114.092585. Epub 2014 Dec 24.
- Background: PubMed 23843134McDonald SJ, Middleton P, Dowswell T, Morris PS. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2013 Jul 11;2013(7):CD004074. doi: 10.1002/14651858.CD004074.pub3.
- Background: PubMed 17374818Hutton EK, Hassan ES. Late vs early clamping of the umbilical cord in full-term neonates: systematic review and meta-analysis of controlled trials. JAMA. 2007 Mar 21;297(11):1241-52. doi: 10.1001/jama.297.11.1241.
- Background: PubMed 20956259Perlman JM, Wyllie J, Kattwinkel J, Atkins DL, Chameides L, Goldsmith JP, Guinsburg R, Hazinski MF, Morley C, Richmond S, Simon WM, Singhal N, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 11: Neonatal resuscitation: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2010 Oct 19;122(16 Suppl 2):S516-38. doi: 10.1161/CIRCULATIONAHA.110.971127. No abstract available.
- Background: PubMed 23168790Committee on Obstetric Practice, American College of Obstetricians and Gynecologists. Committee Opinion No.543: Timing of umbilical cord clamping after birth. Obstet Gynecol. 2012 Dec;120(6):1522-6. doi: 10.1097/01.AOG.0000423817.47165.48.
- Background: PubMed 18137215McCAUSLAND AM, HOLMES F, SCHUMANN WR. Management of cord and placental blood and its effect upon the newborn. Calif Med. 1949 Sep;71(3):190-6.
- Background: PubMed 14923706SIDDALL RS, CRISSEY RR, KNAPP WL. Effect on cesarean section babies of stripping or milking of the umbilical cords. Am J Obstet Gynecol. 1952 May;63(5):1059-64. doi: 10.1016/0002-9378(52)90546-2. No abstract available.
- Background: PubMed 8616446Daniel DG, Weerakkody AN. Neonatal prevention of iron deficiency. Blood can be transfused from cord clamped at placental end. BMJ. 1996 Apr 27;312(7038):1102-3. doi: 10.1136/bmj.312.7038.1102d. No abstract available.
- Background: PubMed 23123382Upadhyay A, Gothwal S, Parihar R, Garg A, Gupta A, Chawla D, Gulati IK. Effect of umbilical cord milking in term and near term infants: randomized control trial. Am J Obstet Gynecol. 2013 Feb;208(2):120.e1-6. doi: 10.1016/j.ajog.2012.10.884. Epub 2012 Oct 31.
- Background: PubMed 22843002Mercer JS, Erickson-Owens DA. Rethinking placental transfusion and cord clamping issues. J Perinat Neonatal Nurs. 2012 Jul-Sep;26(3):202-17; quiz 218-9. doi: 10.1097/JPN.0b013e31825d2d9a.
- Individual participant dataSharing planned: Undecided
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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.
Jianmeng Liu, PhD study chair
Peking University
Hongtian Li, PhD principal investigator
Peking University
Yubo Zhou, PhD principal investigator
Peking University
2 sites 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 Anemia, Iron-Deficiency, run by Peking University at 2 sites in China.
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 4 inclusion and 11 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 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
Change in infant's serum ferritin (μg/L) (time frame: At birth (baseline), 6 and 12 months after birth). 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 NCT02892461, which also lists 10 linked publications.
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 17 Mar 2020.