Clinical trial NCT01245296: Early Versus Delayed Cord Clamping at Term: Outcomes in Swedish Infants
Official title: Early Versus Delayed Cord Clamping at Term: Outcomes in Swedish Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Deficiency
Neonatal Hyperbilirubinemia
Keywords: Umbilical cord
cord clamping
iron
Ferritin
newborn
jaundice
infant
development
infections
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Umeå University
name: Halmstad County Hospital
name: County Council of Halland, Sweden
First posted: 2010-11-22
Enrollment: 392
Sex: ALL
Minimum age (years): 37
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Do time for clamping the umbilical cord affect children's hemoglobin and iron status at 4 months of age?
timeFrame: 4 months of age (plus or minus three weeks)
Secondary outcomes:
measure: Do the time for clamping the umbilical cord affect children's hemoglobin and iron status at 12 months of age?
timeFrame: 12 months of age (plus or minus one month)
measure: Are the rates of successful umbilical arterial samples equal between the groups?
timeFrame: Immediately after birth (within 30 seconds)
measure: Is there a difference in development as assessed by the Ages and Stages Questionnaire at 4 months of age?
timeFrame: 4 months of age (plus or minus three weeks)
measure: Do the time for umbilical cord clamping affect incidence of infections during the first four months of life?
timeFrame: 4 months of age (plus or minus three weeks)
measure: Is Reticulocyte hemoglobin a useful measure of iron stores at 2-3 days of age?
timeFrame: Mean 2 to 3 days of age (within 48-96 hours after birth)
measure: Do the time for umbilical cord clamping affect neonatal outcomes: anemia, polycythemia and need for phototherapy?
timeFrame: Within 7 days after birth
measure: Is there any difference in post partum haemorrhage when using early cord clamping compared to delayed cord clamping with oxytocin administered after clamping?
timeFrame: After giving birth until discharge from maternity ward
measure: Is there a difference in development as assessed by the Ages and Stages Questionnaire at 12 months of age?
timeFrame: 12 months of age (plus or minus one month)
measure: Do the time for umbilical cord clamping affect Immunoglobulin G levels at 2-3 days of age?
timeFrame: Mean 2 to 3 days of age (within 48-96 hours after birth)
measure: Is Reticulocyte hemoglobin a useful measure of iron stores at 12 months of age?
timeFrame: 12 months of age (plus or minus one month)
measure: Does the time for umbilical cord clamping affect the infants respiration within the first 6 hours of life?
timeFrame: Within 6 hours after birth
Other outcomes:
Locations:
city: Halmstad
country: Sweden
facility: Länsjukhuset i Halmstad
state: Halland
Study officials:
affiliation: Uppsala University
name: Ola Andersson, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Umeå University
name: Magnus Domellöf, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.