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Clinical Trials/NCT01487980
NCT01487980
Completed
Not Applicable

The Effect of Delayed Cord Clamping on Haematological Status in Low Birth Weight Infants: a Randomised Controlled Trial in South Africa.

Stanger Hospital1 site in 1 country102 target enrollmentJanuary 2012
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ConditionsLow Birth WeightPerinatologyIron StatusCord Clamping

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Low Birth Weight
Sponsor
Stanger Hospital
Enrollment
102
Locations
1
Primary Endpoint
Haemoglobin level
Status
Completed
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
December 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

S. Tiemersma

Medical Officer

Stanger Hospital

Eligibility 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

  • •twin pregnancy
  • •history of postpartum haemorrhage (PPH)
  • •(gestational) diabetes
  • •pre-eclampsia
  • •abruptio placentae
  • •caesarian section
  • •necessity of early clamping due to tight nuchal cord
  • •need for resuscitation immediately after birth
  • •major congenital abnormalities

Outcomes

Primary Outcomes

Haemoglobin level

Time Frame: two months

Secondary Outcomes

  • Hyperviscosity syndrome(1 day)
  • Iron status(two months)
  • hyperbilirubinaemia(2 days)

Study Sites (1)

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