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

August 19, 2014 updated by: Uppsala University

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

392

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Halland
      • Halmstad, Halland, Sweden, 30187
        • Länsjukhuset i Halmstad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 months to 9 months (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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 Names:
  • Delayed cord clamping is also called Late cord claming
OTHER: 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 Names:
  • Delayed cord clamping is also called Late cord claming

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months of age (plus or minus three weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months of age (plus or minus one month)
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.
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?
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 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?
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.
4 months of age (plus or minus three weeks)
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
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?
Time Frame: Within 7 days after birth
Anemia defined as hemoglobin < 145 g/L, polycythemia defined as hematocrit > 0.65.
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?
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
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?
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.
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?
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.
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?
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
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?
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.
Within 6 hours after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Umeå University
Halmstad County Hospital
County Council of Halland, Sweden

Investigators

  • Principal Investigator: Ola Andersson, M.D., Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

May 1, 2010

Study Registration Dates

First Submitted

October 13, 2010

First Submitted That Met QC Criteria

November 19, 2010

First Posted (ESTIMATE)

November 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 20, 2014

Last Update Submitted That Met QC Criteria

August 19, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NATIBAR08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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