Iron DeficiencyNCT01245296
Early Versus Delayed Cord Clamping at Term: Outcomes in Swedish Infants
A study testing Timing of clamping the umbilical cord in people with Iron Deficiency and Neonatal Hyperbilirubinemia, run by Uppsala University at 1 site in Sweden.
Trial summary
Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by increasing the infant's iron endowment at birth. Compared with early clamping, a delay of around 2-3 min provides an additional 25-40 mL of blood per kg of bodyweight. Read more about this study
- Who is it for?
- Ages 37 to 42 weeksHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency, Neonatal Hyperbilirubinemia
- What is being tested?
- Timing of clamping the umbilical cord
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2008to May 2010
- 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 37 to 42 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- non-smoking mother
- healthy mother (no hemolytic disease, no treatment with any of the following drugs: anticonvulsants, antidepressants, thyroid hormone, insulin, chemotherapy or cortisone),
- normal pregnancy (no preeclampsia, no diabetes, no prolonged rupture of membranes or signs of infection)
- single birth, term pregnancy (gestational age 37 +0 until 41 +6 weeks + days)
- expected vaginal delivery with cephalic presentation
- mother should be able to master Swedish well enough to participate in the study
- mother should live close enough to the hospital to be ready to return for follow up after four months.
Who cannot join
- Serious congenital malformation, syndrome or other congenital disease that can affect the outcome measures
Trial locations and contacts
1 site in 1 country.
About this study
Delayed clamping of the umbilical cord might prevent or slow the onset of iron deficiency by increasing the infant's iron endowment at birth. Compared with early clamping, a delay of around 2-3 min provides an additional 25-40 mL of blood per kg of bodyweight.
The results of previous intervention studies on delayed clamping are mixed, and few followed up infants beyond the perinatal period. All longer follow up studies have been performed in low income countries. The main objectives, therefore, was to assess whether delayed cord clamping improves hematological and iron status at 4 respective 12 months of age in a large sample of full-term, Swedish infants.
The investigators also choose to investigate if the timing of clamping the umbilical cord could affect rate of infections during the first four months of life and to assess the infants development at 4 and 12 months of age.
- Conditions
- Iron Deficiency, Neonatal Hyperbilirubinemia
- Being tested
- Timing of clamping the umbilical cord
- Keywords
- Umbilical cord, cord clamping, iron, Ferritin, newborn, jaundice, infant, development, infections
- Medical subject headings
- Iron Deficiencies, Hyperbilirubinemia, Neonatal, Jaundice, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Timing of clamping the umbilical cordProcedure or surgery
Also called Delayed cord clamping is also called Late cord claming
The time passed after delivery until that the midwife stops circulation in the umbilical cord with a clamp.
| Study group | Role | What they receive |
|---|---|---|
| Early cord clamping (ECC) | Other | Early cord clamping consisted of early (< 10 s) clamping of the umbilical cord and obtaining blood gas samples after clamping. Receives: Procedure: Timing of clamping the umbilical cord |
| Delayed cord clamping (DCC) | Other | Delayed cord clamping consisted of delayed (> 180 s) clamping of the umbilical cord and obtaining blood gas samples before clamping (within 30 seconds). Receives: Procedure: Timing of clamping the umbilical cord |
What is being measured
The primary outcome is the main question the study is designed to answer.
Do time for clamping the umbilical cord affect children's hemoglobin and iron status at 4 months of age?
Using mean cell volume (MCV), mean cell hemoglobin concentration (MCHC), reticulocyte hemoglobin, serum ferritin, transferrin saturation and soluble transferrin receptors to assess iron status
Measured: 4 months of age (plus or minus three weeks)
Secondary outcomes (11)
Do the time for clamping the umbilical cord affect children's hemoglobin and iron status at 12 months of age?
Using mean cell volume (MCV), mean cell hemoglobin concentration (MCHC), reticulocyte hemoglobin, serum ferritin, transferrin saturation and soluble transferrin receptors to assess iron status.
Measured: 12 months of age (plus or minus one month)
Are the rates of successful umbilical arterial samples equal between the groups?
Arterial blood samples are obtained with different methods between groups: in the early clamped group samples are taken from the placental part of the clamped cord, in the delayed clamped group samples are taken before clamping in the still pulsating cord. At the same time umbilical venous samples are obtained. A arterial blood sample is assessed as successful when ph < 0.2 and partial pressure of carbon dioxide (pCO2) > 0.5 kPa compared to the venous sample.
Measured: Immediately after birth (within 30 seconds)
Is there a difference in development as assessed by the Ages and Stages Questionnaire at 4 months of age?
Ages and Stages Questionnaire is a parent report questionnaire available for developmental screening of children from one month to 5 ½ years. 30 questions are divided into 5 developmental domains (communication, gross motor, fine motor, problem solving and personal-social). Total score and scores within separate domains from the 4-month questionnaire will be assessed.
Measured: 4 months of age (plus or minus three weeks)
Do the time for umbilical cord clamping affect incidence of infections during the first four months of life?
After birth of their child, until four months of age parents fill out a form where they daily note if their infant has intestinal or respiratory symptoms, as well as if the infant has middle ear infection, has visited a doctor, has had an antibiotic prescription or has been admitted into a hospital.
Measured: 4 months of age (plus or minus three weeks)
Is Reticulocyte hemoglobin a useful measure of iron stores at 2-3 days of age?
Reticulocyte hemoglobin (RetHE) is a novel measure suggested to describe iron status. Ret HE will be compared to other indicators of iron stores: mean cell volume (MCV), mean cell hemoglobin concentration (MCHC), serum ferritin, transferrin saturation and soluble transferrin receptors
Measured: Mean 2 to 3 days of age (within 48-96 hours after birth)
Do the time for umbilical cord clamping affect neonatal outcomes: anemia, polycythemia and need for phototherapy?
Anemia defined as hemoglobin < 145 g/L, polycythemia defined as hematocrit > 0.65.
Measured: Within 7 days after birth
Is there any difference in post partum haemorrhage when using early cord clamping compared to delayed cord clamping with oxytocin administered after clamping?
Measuring time to placental abortion, post partal hemorrhage and mothers post partum need for blood transfusion
Measured: After giving birth until discharge from maternity ward
Is there a difference in development as assessed by the Ages and Stages Questionnaire at 12 months of age?
Ages and Stages Questionnaire is a parent report questionnaire available for developmental screening of children from one month to 5 ½ years. 30 questions are divided into 5 developmental domains (communication, gross motor, fine motor, problem solving and personal-social). Total score and scores within separate domains from the 12-month questionnaire will be assessed.
Measured: 12 months of age (plus or minus one month)
Do the time for umbilical cord clamping affect Immunoglobulin G levels at 2-3 days of age?
Blood samples for metabolic screening are routinely taken as soon as possible after 2 days (48 hours) of age. At the same time samples for Immunoglobulin G is obtained.
Measured: Mean 2 to 3 days of age (within 48-96 hours after birth)
Is Reticulocyte hemoglobin a useful measure of iron stores at 12 months of age?
Reticulocyte hemoglobin (RetHE) is a novel measure suggested to describe iron status. Ret HE will be compared to other indicators of iron stores: mean cell volume (MCV), mean cell hemoglobin concentration (MCHC), serum ferritin, transferrin saturation and soluble transferrin receptors
Measured: 12 months of age (plus or minus one month)
Does the time for umbilical cord clamping affect the infants respiration within the first 6 hours of life?
Midwives observes the newborn infant at 1 hour and 6 hours of age and note presence of tachypnea (> 60 breaths/minute), grunting, nostril flaring and or retractions between or under the ribs.
Measured: Within 6 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 posted22 Nov 2010 (estimated)
- Study startApr 2008
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by Uppsala 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
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Umeå University, Halmstad County Hospital, County Council of Halland, Sweden
- Responsible party
- Sponsor
- Investigators
- Ola Andersson, M.D., Principal investigator, Uppsala UniversityMagnus Domellöf, MD, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01245296
- Sponsor's protocol ID
- NATIBAR08
- Status last verified
- Aug 2014
- First submitted
- 13 Oct 2010
- Last updated
- 20 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Begley CM, Gyte GM, Murphy DJ, Devane D, McDonald SJ, McGuire W. Active versus expectant management for women in the third stage of labour. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD007412. doi: 10.1002/14651858.CD007412.pub2.
PubMed 20614458Chaparro CM, Fornes R, Neufeld LM, Tena Alavez G, Eguia-Liz Cedillo R, Dewey KG. Early umbilical cord clamping contributes to elevated blood lead levels among infants with higher lead exposure. J Pediatr. 2007 Nov;151(5):506-12. doi: 10.1016/j.jpeds.2007.04.056. Epub 2007 Sep 17.
PubMed 17961694Ceriani Cernadas JM, Carroli G, Pellegrini L, Otano L, Ferreira M, Ricci C, Casas O, Giordano D, Lardizabal J. The effect of timing of cord clamping on neonatal venous hematocrit values and clinical outcome at term: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):e779-86. doi: 10.1542/peds.2005-1156. Epub 2006 Mar 27.
PubMed 16567393van Rheenen P, de Moor L, Eschbach S, de Grooth H, Brabin B. Delayed cord clamping and haemoglobin levels in infancy: a randomised controlled trial in term babies. Trop Med Int Health. 2007 May;12(5):603-16. doi: 10.1111/j.1365-3156.2007.01835.x.
PubMed 17445128van Rheenen PF, Gruschke S, Brabin BJ. Delayed umbilical cord clamping for reducing anaemia in low birthweight infants: implications for developing countries. Ann Trop Paediatr. 2006 Sep;26(3):157-67. doi: 10.1179/146532806X120246.
PubMed 16925952Hutton 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 17374818Grajeda R, Perez-Escamilla R, Dewey KG. Delayed clamping of the umbilical cord improves hematologic status of Guatemalan infants at 2 mo of age. Am J Clin Nutr. 1997 Feb;65(2):425-31. doi: 10.1093/ajcn/65.2.425.
PubMed 9022526McDonald SJ, Middleton P. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004074. doi: 10.1002/14651858.CD004074.pub2.
PubMed 18425897Mercer JS. Current best evidence: a review of the literature on umbilical cord clamping. J Midwifery Womens Health. 2001 Nov-Dec;46(6):402-14. doi: 10.1016/s1526-9523(01)00196-9.
PubMed 11783688Andersson O, Hellstrom-Westas L, Andersson D, Domellof M. Effect of delayed versus early umbilical cord clamping on neonatal outcomes and iron status at 4 months: a randomised controlled trial. BMJ. 2011 Nov 15;343:d7157. doi: 10.1136/bmj.d7157.
PubMed 22089242Andersson O, Domellof M, Andersson D, Hellstrom-Westas L. Effect of delayed vs early umbilical cord clamping on iron status and neurodevelopment at age 12 months: a randomized clinical trial. JAMA Pediatr. 2014 Jun;168(6):547-54. doi: 10.1001/jamapediatrics.2013.4639.
PubMed 24756128Andersson O, Domellof M, Andersson D, Hellstrom-Westas L. Effects of delayed cord clamping on neurodevelopment and infection at four months of age: a randomised trial. Acta Paediatr. 2013 May;102(5):525-31. doi: 10.1111/apa.12168. Epub 2013 Feb 11.
PubMed 23336628Andersson O, Hellstrom-Westas L, Andersson D, Clausen J, Domellof M. Effects of delayed compared with early umbilical cord clamping on maternal postpartum hemorrhage and cord blood gas sampling: a randomized trial. Acta Obstet Gynecol Scand. 2013 May;92(5):567-74. doi: 10.1111/j.1600-0412.2012.01530.x. Epub 2012 Oct 17.
PubMed 22913332Askelof U, Andersson O, Domellof M, Fasth A, Hallberg B, Hellstrom-Westas L, Pettersson K, Westgren M, Wiklund IE, Gotherstrom C. Wait a minute? An observational cohort study comparing iron stores in healthy Swedish infants at 4 months of age after 10-, 60- and 180-second umbilical cord clamping. BMJ Open. 2017 Dec 29;7(12):e017215. doi: 10.1136/bmjopen-2017-017215.
PubMed 29289934
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Delayed Cord Clamping at Term: Outcomes in Swedish Infants
- ClinicalTrials.gov ID
- NCT01245296
- Acronym / sponsor ID
- NATIBAR08
- Conditions
- Iron Deficiency, Neonatal Hyperbilirubinemia
- Keywords
- Umbilical cord, cord clamping, iron, Ferritin, newborn, jaundice, infant, development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Umeå University, Halmstad County Hospital, County Council of Halland, Sweden
- Study start
- Apr 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 22 Nov 2010 (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 clamping of the umbilical cord might prevent or slow the onset of iron deficiency by increasing the infant's iron endowment at birth. Compared with early clamping, a delay of around 2-3 min provides an additional 25-40 mL of blood per kg of bodyweight.
The results of previous intervention studies on delayed clamping are mixed, and few followed up infants beyond the perinatal period. All longer follow up studies have been performed in low income countries. The main objectives, therefore, was to assess whether delayed cord clamping improves hematological and iron status at 4 respective 12 months of age in a large sample of full-term, Swedish infants.
The investigators also choose to investigate if the timing of clamping the umbilical cord could affect rate of infections during the first four months of life and to assess the infants development at 4 and 12 months of age.
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 |
|---|---|---|
| Early cord clamping (ECC) | Other | Procedure: Timing of clamping the umbilical cordEarly cord clamping consisted of early (< 10 s) clamping of the umbilical cord and obtaining blood gas samples after clamping. |
| Delayed cord clamping (DCC) | Other | Procedure: Timing of clamping the umbilical cordDelayed cord clamping consisted of delayed (> 180 s) clamping of the umbilical cord and obtaining blood gas samples before clamping (within 30 seconds). |
Who may qualify
- Ages
- 37 to 42 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- non-smoking mother
- healthy mother (no hemolytic disease, no treatment with any of the following drugs: anticonvulsants, antidepressants, thyroid hormone, insulin, chemotherapy or cortisone),
- normal pregnancy (no preeclampsia, no diabetes, no prolonged rupture of membranes or signs of infection)
- single birth, term pregnancy (gestational age 37 +0 until 41 +6 weeks + days)
- expected vaginal delivery with cephalic presentation
Key exclusion criteria (1 listed)
- Serious congenital malformation, syndrome or other congenital disease that can affect the outcome measures
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 |
|---|---|---|
| Timing of clamping the umbilical cordAlso: Delayed cord clamping is also called Late cord clamingThe time passed after delivery until that the midwife stops circulation in the umbilical cord with a clamp. | Procedure or surgery | Delayed cord clamping (DCC), Early cord clamping (ECC) |
Primary outcome
Do time for clamping the umbilical cord affect children's hemoglobin and iron status at 4 months of age?
Time frame: 4 months of age (plus or minus three weeks)
Using mean cell volume (MCV), mean cell hemoglobin concentration (MCHC), reticulocyte hemoglobin, serum ferritin, transferrin saturation and soluble transferrin receptors to assess iron status
11 secondary outcomes
Do the time for clamping the umbilical cord affect children's hemoglobin and iron status at 12 months of age?
Time frame: 12 months of age (plus or minus one month)
Are the rates of successful umbilical arterial samples equal between the groups?
Time frame: Immediately after birth (within 30 seconds)
Is there a difference in development as assessed by the Ages and Stages Questionnaire at 4 months of age?
Time frame: 4 months of age (plus or minus three weeks)
Do the time for umbilical cord clamping affect incidence of infections during the first four months of life?
Time frame: 4 months of age (plus or minus three weeks)
Is Reticulocyte hemoglobin a useful measure of iron stores at 2-3 days of age?
Time frame: Mean 2 to 3 days of age (within 48-96 hours after birth)
Do the time for umbilical cord clamping affect neonatal outcomes: anemia, polycythemia and need for phototherapy?
Time frame: Within 7 days after birth
Is there any difference in post partum haemorrhage when using early cord clamping compared to delayed cord clamping with oxytocin administered after clamping?
Time frame: After giving birth until discharge from maternity ward
Is there a difference in development as assessed by the Ages and Stages Questionnaire at 12 months of age?
Time frame: 12 months of age (plus or minus one month)
Do the time for umbilical cord clamping affect Immunoglobulin G levels at 2-3 days of age?
Time frame: Mean 2 to 3 days of age (within 48-96 hours after birth)
Is Reticulocyte hemoglobin a useful measure of iron stores at 12 months of age?
Time frame: 12 months of age (plus or minus one month)
Does the time for umbilical cord clamping affect the infants respiration within the first 6 hours of life?
Time frame: Within 6 hours after 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 20 Aug 2014.
- Background: PubMed 20614458Begley CM, Gyte GM, Murphy DJ, Devane D, McDonald SJ, McGuire W. Active versus expectant management for women in the third stage of labour. Cochrane Database Syst Rev. 2010 Jul 7;(7):CD007412. doi: 10.1002/14651858.CD007412.pub2.
- Background: PubMed 17961694Chaparro CM, Fornes R, Neufeld LM, Tena Alavez G, Eguia-Liz Cedillo R, Dewey KG. Early umbilical cord clamping contributes to elevated blood lead levels among infants with higher lead exposure. J Pediatr. 2007 Nov;151(5):506-12. doi: 10.1016/j.jpeds.2007.04.056. Epub 2007 Sep 17.
- Background: PubMed 16567393Ceriani Cernadas JM, Carroli G, Pellegrini L, Otano L, Ferreira M, Ricci C, Casas O, Giordano D, Lardizabal J. The effect of timing of cord clamping on neonatal venous hematocrit values and clinical outcome at term: a randomized, controlled trial. Pediatrics. 2006 Apr;117(4):e779-86. doi: 10.1542/peds.2005-1156. Epub 2006 Mar 27.
- Background: PubMed 17445128van Rheenen P, de Moor L, Eschbach S, de Grooth H, Brabin B. Delayed cord clamping and haemoglobin levels in infancy: a randomised controlled trial in term babies. Trop Med Int Health. 2007 May;12(5):603-16. doi: 10.1111/j.1365-3156.2007.01835.x.
- Background: PubMed 16925952van Rheenen PF, Gruschke S, Brabin BJ. Delayed umbilical cord clamping for reducing anaemia in low birthweight infants: implications for developing countries. Ann Trop Paediatr. 2006 Sep;26(3):157-67. doi: 10.1179/146532806X120246.
- 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 9022526Grajeda R, Perez-Escamilla R, Dewey KG. Delayed clamping of the umbilical cord improves hematologic status of Guatemalan infants at 2 mo of age. Am J Clin Nutr. 1997 Feb;65(2):425-31. doi: 10.1093/ajcn/65.2.425.
- Background: PubMed 18425897McDonald SJ, Middleton P. Effect of timing of umbilical cord clamping of term infants on maternal and neonatal outcomes. Cochrane Database Syst Rev. 2008 Apr 16;(2):CD004074. doi: 10.1002/14651858.CD004074.pub2.
- Background: PubMed 11783688Mercer JS. Current best evidence: a review of the literature on umbilical cord clamping. J Midwifery Womens Health. 2001 Nov-Dec;46(6):402-14. doi: 10.1016/s1526-9523(01)00196-9.
- Results publication: PubMed 22089242Andersson O, Hellstrom-Westas L, Andersson D, Domellof M. Effect of delayed versus early umbilical cord clamping on neonatal outcomes and iron status at 4 months: a randomised controlled trial. BMJ. 2011 Nov 15;343:d7157. doi: 10.1136/bmj.d7157.
- Results publication: PubMed 24756128Andersson O, Domellof M, Andersson D, Hellstrom-Westas L. Effect of delayed vs early umbilical cord clamping on iron status and neurodevelopment at age 12 months: a randomized clinical trial. JAMA Pediatr. 2014 Jun;168(6):547-54. doi: 10.1001/jamapediatrics.2013.4639.
- Results publication: PubMed 23336628Andersson O, Domellof M, Andersson D, Hellstrom-Westas L. Effects of delayed cord clamping on neurodevelopment and infection at four months of age: a randomised trial. Acta Paediatr. 2013 May;102(5):525-31. doi: 10.1111/apa.12168. Epub 2013 Feb 11.
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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.
Ola Andersson, M.D. principal investigator
Uppsala University
Magnus Domellöf, MD, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timing of clamping the umbilical cord in people with Iron Deficiency and Neonatal Hyperbilirubinemia, run by Uppsala University at 1 site in Sweden.
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 7 inclusion and 1 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 20 Aug 2014. 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 Sweden. 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?
Do time for clamping the umbilical cord affect children's hemoglobin and iron status at 4 months of age? (time frame: 4 months of age (plus or minus three weeks)). 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 NCT01245296, which also lists 14 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 20 Aug 2014.