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NCT01487980 Clinical Trial

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

Low Birth Weight Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01487980
Other study ID # DCC-LBW-SA
Secondary ID
Status Completed
Phase N/A
First received December 5, 2011
Last updated December 15, 2012
Start date January 2012
Est. completion date December 2012

Study information
Verified date December 2012
Source Stanger Hospital
Contact n/a
Is FDA regulated No
Health authority South Africa: Department of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 45 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Intervention

Procedure:
• Cord clamping
Early vs Delayed

Locations
Country Name City State
South Africa Stanger Hospital Stanger KwaZulu-Natal

Sponsors (2)
Lead Sponsor Collaborator
Stanger Hospital Otto Kranendonk Fonds - Dutch Association of Tropical Health (request pending)

Country where clinical trial is conducted

South Africa, 

Outcome
Type Measure Description Time frame Safety issue
Primary Haemoglobin level two months No
Secondary Hyperviscosity syndrome 1 day Yes
Secondary Iron status two months No
Secondary hyperbilirubinaemia 2 days Yes
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