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Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants

This study has been completed.
Sponsor:
Collaborator:
Otto Kranendonk Fonds - Dutch Association of Tropical Health (request pending)
Information provided by (Responsible Party):
S. Tiemersma, Stanger Hospital
ClinicalTrials.gov Identifier:
NCT01487980
First received: December 5, 2011
Last updated: December 15, 2012
Last verified: December 2012
History of Changes
  Purpose

Delayed cord clamping (DCC, clamping after cessation of pulsations in the cord around 2-3 min after delivery) is effective in increasing (low birth weight) infant haemoglobin and iron status until six months after birth, without increasing the risk of polycythaemia or other adverse events. We hypothesize that this intervention will also benefit low birth weight infants in South Africa.


Condition Intervention
Low Birth Weight
Perinatology
Iron Status
Cord Clamping
 Procedure: Cord clamping

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants: a Randomised Controlled Trial in South Africa.

Resource links provided by NLM:

MedlinePlus related topics: Birth Weight Iron
U.S. FDA Resources

Further study details as provided by Stanger Hospital:

Primary Outcome Measures:
  • Haemoglobin level [ Time Frame: two months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hyperviscosity syndrome [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
  • Iron status [ Time Frame: two months ] [ Designated as safety issue: No ]
  • hyperbilirubinaemia [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 102
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Early cord clamping
Within 30 seconds after birth.
 Procedure: Cord clamping
Early vs Delayed
Experimental: Delayed cord clamping
Between 2 and 3 minutes after birth
 Procedure: Cord clamping
Early vs Delayed

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant mothers with SFH measurements below the cutpoint are eligible for inclusion. We aim to include infants with a birth weight below 2500 grams, but the actual birthweight can only be assessed after birth. We therefore accept an error of 500 grams (20%) and will include newborns up to 3000 grams. Birthweight will be measured after randomisation and study treatment.

Exclusion Criteria:

  1. twin pregnancy
  2. history of postpartum haemorrhage (PPH)
  3. (gestational) diabetes
  4. pre-eclampsia
  5. abruptio placentae
  6. caesarian section
  7. necessity of early clamping due to tight nuchal cord
  8. need for resuscitation immediately after birth
  9. major congenital abnormalities
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01487980

Locations
South Africa
Stanger Hospital
Stanger, KwaZulu-Natal, South Africa, 4450
Sponsors and Collaborators
Stanger Hospital
Otto Kranendonk Fonds - Dutch Association of Tropical Health (request pending)
Investigators
Principal Investigator: Sybrich Tiemersma, MD Stanger Hospital
  More Information

No publications provided

Responsible Party: S. Tiemersma, Medical Officer, Stanger Hospital
ClinicalTrials.gov Identifier: NCT01487980     History of Changes
Other Study ID Numbers: DCC-LBW-SA
Study First Received: December 5, 2011
Last Updated: December 15, 2012
Health Authority: South Africa: Department of Health

Additional relevant MeSH terms:
Birth Weight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013