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

This study has been completed.
Sponsor:
Collaborators:
Umeå University
Halmstad County Hospital
County Council of Halland, Sweden
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01245296
First received: October 13, 2010
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Iron Deficiency
Neonatal Hyperbilirubinemia
Procedure: Timing of clamping the umbilical cord

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early Versus Delayed Cord Clamping at Term: Outcomes in Swedish Infants

Resource links provided by NLM:


Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
    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:
  • 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) ] [ Designated as safety issue: No ]
    Using mean cell volume (MCV), mean cell hemoglobin concentration (MCHC), reticulocyte hemoglobin, serum ferritin, transferrin saturation and soluble transferrin receptors to assess iron status.

  • Are the rates of successful umbilical arterial samples equal between the groups? [ Time Frame: Immediately after birth (within 30 seconds) ] [ Designated as safety issue: No ]
    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? [ Time Frame: 4 months of age (plus or minus three weeks) ] [ Designated as safety issue: No ]
    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? [ Time Frame: 4 months of age (plus or minus three weeks) ] [ Designated as safety issue: No ]
    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? [ Time Frame: Mean 2 to 3 days of age (within 48-96 hours after birth) ] [ Designated as safety issue: No ]
    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 umbilical cord clamping affect neonatal outcomes: anemia, polycythemia and need for phototherapy? [ Time Frame: Within 7 days after birth ] [ Designated as safety issue: Yes ]
    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? [ Time Frame: After giving birth until discharge from maternity ward ] [ Designated as safety issue: Yes ]
    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? [ Time Frame: 12 months of age (plus or minus one month) ] [ Designated as safety issue: No ]
    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? [ Time Frame: Mean 2 to 3 days of age (within 48-96 hours after birth) ] [ Designated as safety issue: No ]
    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? [ Time Frame: 12 months of age (plus or minus one month) ] [ Designated as safety issue: No ]
    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? [ Time Frame: Within 6 hours after birth ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 392
Study Start Date: April 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Early cord clamping (ECC)
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
The time passed after delivery until that the midwife stops circulation in the umbilical cord with a clamp.
Other Name: Delayed cord clamping is also called Late cord claming
Delayed cord clamping (DCC)
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
The time passed after delivery until that the midwife stops circulation in the umbilical cord with a clamp.
Other Name: Delayed cord clamping is also called Late cord claming

  Eligibility

Ages Eligible for Study:   37 Weeks to 42 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245296

Locations
Sweden
Länsjukhuset i Halmstad
Halmstad, Halland, Sweden, 30187
Sponsors and Collaborators
Uppsala University
Umeå University
Halmstad County Hospital
County Council of Halland, Sweden
Investigators
Principal Investigator: Ola Andersson, M.D. Uppsala University
Principal Investigator: Magnus Domellöf, MD, PhD Umeå University
  More Information

Publications:

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01245296     History of Changes
Other Study ID Numbers: NATIBAR08
Study First Received: October 13, 2010
Last Updated: August 19, 2014
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Uppsala University:
Umbilical cord
cord clamping
iron
Ferritin
newborn
jaundice
infant
development
infections

Additional relevant MeSH terms:
Hyperbilirubinemia
Anemia, Iron-Deficiency
Hyperbilirubinemia, Neonatal
Pathologic Processes
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on August 21, 2014