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Completed

NCT Number: NCT01245296

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

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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Key information

Conditions

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

Age range

37 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Länsjukhuset i Halmstad

Halmstad, Halland County, 30187, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Delayed cord clamping is also called Late cord claming

Primary outcomes

  1. Do time for clamping the umbilical cord affect children's hemoglobin and iron status at 4 months of age?

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

  3. Is there a difference in development as assessed by the Ages and Stages Questionnaire at 4 months of age?

    Time frame: 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.

  4. Do the time for umbilical cord clamping affect incidence of infections during the first four months of life?

    Time frame: 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.

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

    Time frame: 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

  6. Do the time for umbilical cord clamping affect neonatal outcomes: anemia, polycythemia and need for phototherapy?

    Time frame: Within 7 days after birth

    Anemia defined as hemoglobin < 145 g/L, polycythemia defined as hematocrit > 0.65.

  7. Is there any difference in post partum haemorrhage when using early cord clamping compared to delayed cord clamping with oxytocin administered after clamping?

    Time frame: After giving birth until discharge from maternity ward

    Measuring time to placental abortion, post partal hemorrhage and mothers post partum need for blood transfusion

  8. Is there a difference in development as assessed by the Ages and Stages Questionnaire at 12 months of age?

    Time frame: 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.

  9. Do the time for umbilical cord clamping affect Immunoglobulin G levels at 2-3 days of age?

    Time frame: 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.

  10. Is Reticulocyte hemoglobin a useful measure of iron stores at 12 months of age?

    Time frame: 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

  11. Does the time for umbilical cord clamping affect the infants respiration within the first 6 hours of life?

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • County Council of Halland, Sweden
  • Halmstad County Hospital
  • Umeå University

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 22, 2010
Registry last updated
Aug 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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