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| Name | Class |
|---|---|
| Umeå University | OTHER |
| Halmstad County Hospital | OTHER |
| County Council of Halland, Sweden | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timing of clamping the umbilical cord | Procedure | The time passed after delivery until that the midwife stops circulation in the umbilical cord with a clamp. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 months of age (plus or minus three weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months of age (plus or minus one month) |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ola Andersson, M.D. | Uppsala University | Principal Investigator |
| Magnus Domellöf, MD, PhD | Umeå University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Länsjukhuset i Halmstad | Halmstad | Halland County | 30187 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20614458 | Background | 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. | |
| 17961694 | Background | Chaparro 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. |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D051556 | Hyperbilirubinemia, Neonatal |
| D007565 | Jaundice |
| D007239 | Infections |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007232 | Infant, Newborn, Diseases |
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|
| 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. | 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. | 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. | 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 | 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. | 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 | 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. | 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. | 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 | 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. | Within 6 hours after birth |
| 16567393 | Background | Ceriani 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. |
| 17445128 | Background | van 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. |
| 16925952 | Background | van 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. |
| 17374818 | Background | Hutton 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. |
| 9022526 | Background | Grajeda 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. |
| 18425897 | Background | McDonald 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. |
| 11783688 | Background | Mercer 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. |
| 22089242 | Result | Andersson 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. |
| 24756128 | Result | Andersson 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. |
| 23336628 | Result | Andersson 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. |
| 22913332 | Result | Andersson 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. |
| 29289934 | Derived | Askelof 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. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |