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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
392
The time passed after delivery until that the midwife stops circulation in the umbilical cord with a clamp.
Länsjukhuset i Halmstad
Halmstad, Halland County, Sweden
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
Time frame: 4 months of age (plus or minus three weeks)
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.
Time frame: 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.
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?
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.
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?
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.
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?
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
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?
Anemia defined as hemoglobin \< 145 g/L, polycythemia defined as hematocrit \> 0.65.
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?
Measuring time to placental abortion, post partal hemorrhage and mothers post partum need for blood transfusion
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?
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.
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?
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.
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?
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
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?
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.
Time frame: Within 6 hours after birth
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