Early Versus Delayed Cord Clamping at Term: Outcomes in Swedish Infants
- Conditions
- Neonatal HyperbilirubinemiaIron Deficiency
- Interventions
- Procedure: Timing of clamping the umbilical cord
- Registration Number
- NCT01245296
- Lead Sponsor
- Uppsala University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 392
- 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.
- Serious congenital malformation, syndrome or other congenital disease that can affect the outcome measures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Early cord clamping (ECC) Timing of clamping the umbilical cord Early cord clamping consisted of early (\< 10 s) clamping of the umbilical cord and obtaining blood gas samples after clamping. Delayed cord clamping (DCC) Timing of clamping the umbilical cord Delayed cord clamping consisted of delayed (\> 180 s) clamping of the umbilical cord and obtaining blood gas samples before clamping (within 30 seconds).
- Primary Outcome Measures
Name Time Method Do time for clamping the umbilical cord affect children's hemoglobin and iron status at 4 months of age? 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
- Secondary Outcome Measures
Name Time Method Are the rates of successful umbilical arterial samples equal between the groups? Immediately after birth (within 30 seconds) 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.
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) 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.
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) 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.
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) 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
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) Using mean cell volume (MCV), mean cell hemoglobin concentration (MCHC), reticulocyte hemoglobin, serum ferritin, transferrin saturation and soluble transferrin receptors to assess iron status.
Do the time for umbilical cord clamping affect neonatal outcomes: anemia, polycythemia and need for phototherapy? Within 7 days after birth Anemia defined as hemoglobin \< 145 g/L, polycythemia defined as hematocrit \> 0.65.
Is there any difference in post partum haemorrhage when using early cord clamping compared to delayed cord clamping with oxytocin administered after clamping? After giving birth until discharge from maternity ward Measuring time to placental abortion, post partal hemorrhage and mothers post partum need for blood transfusion
Is there a difference in development as assessed by the Ages and Stages Questionnaire at 12 months of age? 12 months of age (plus or minus one month) 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.
Do the time for umbilical cord clamping affect Immunoglobulin G levels at 2-3 days of age? Mean 2 to 3 days of age (within 48-96 hours after birth) 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.
Is Reticulocyte hemoglobin a useful measure of iron stores at 12 months of age? 12 months of age (plus or minus one month) 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
Does the time for umbilical cord clamping affect the infants respiration within the first 6 hours of life? Within 6 hours after birth 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.
Trial Locations
- Locations (1)
Länsjukhuset i Halmstad
🇸🇪Halmstad, Halland, Sweden