Early Versus Delayed Cord Clamping at Term: Outcomes in Swedish Infants

NCT01245296 | Completed

• 1 other identifier: NATIBAR08
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Umbilical cord; cord clamping; iron; Ferritin; newborn; jaundice; infant; development; infections

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (11)

• Do the time for clamping the umbilical cord affect children's hemoglobin and iron status at 12 months of age?

  12 months of age (plus or minus one month)

• Are the rates of successful umbilical arterial samples equal between the groups?

  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?

  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?

  4 months of age (plus or minus three weeks)

• Is Reticulocyte hemoglobin a useful measure of iron stores at 2-3 days of age?

  Mean 2 to 3 days of age (within 48-96 hours after birth)

Study Arms (2)

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.

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).

Procedure: Timing of clamping the umbilical cord

Interventions

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.

Also known as: Delayed cord clamping is also called Late cord claming

Delayed cord clamping (DCC); Early cord clamping (ECC)

Eligibility Criteria

• Age: 37 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Serious congenital malformation, syndrome or other congenital disease that can affect the outcome measures

Sponsors & Collaborators

• Uppsala University: lead
• Umeå University: collaborator
• Halmstad County Hospital: collaborator
• County Council of Halland, Sweden: collaborator

Study Sites (1)

Länsjukhuset i Halmstad

Halmstad, Halland County, 30187, Sweden

Location

Related Publications (14)

• 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.

  PMID: 20614458 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.

  PMID: 17961694 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.

  PMID: 16567393 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.

  PMID: 17445128 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.

  PMID: 16925952 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.

  PMID: 17374818 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.

  PMID: 9022526 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.

  PMID: 18425897 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.

  PMID: 11783688 BACKGROUND

• 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.

  PMID: 22089242 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.

  PMID: 24756128 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.

  PMID: 23336628 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.

  PMID: 22913332 RESULT

• 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.

  PMID: 29289934 DERIVED

MeSH Terms

Conditions

Iron Deficiencies; Hyperbilirubinemia, Neonatal; Jaundice; Infections

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Ola Andersson, M.D.

  Uppsala University

  PRINCIPAL INVESTIGATOR

• Magnus Domellöf, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2010
• First Posted: November 22, 2010
• Study Start: April 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: August 20, 2014

Record last verified: 2014-08

Locations

SE (1)