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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
  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
Intervention Model: Parallel Assignment
Masking: Single (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:


Further study details as provided by S. Tiemersma, Stanger Hospital:

Primary Outcome Measures:
  • Haemoglobin level [ Time Frame: two months ]

Secondary Outcome Measures:
  • Hyperviscosity syndrome [ Time Frame: 1 day ]
  • Iron status [ Time Frame: two months ]
  • hyperbilirubinaemia [ Time Frame: 2 days ]

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   (Adult)
Sexes Eligible for Study:   All
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
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: 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

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

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

ClinicalTrials.gov processed this record on August 18, 2017