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.
Verified date | December 2012 |
Source | Stanger Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Africa: Department of Health |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
South Africa | Stanger Hospital | Stanger | KwaZulu-Natal |
Lead Sponsor | Collaborator |
---|---|
Stanger Hospital | Otto Kranendonk Fonds - Dutch Association of Tropical Health (request pending) |
South Africa,
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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