Cord Clamping, Iron Status, Low Birth Weight, Perinatology
Conditions
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.
Interventions
PROCEDURECord clamping
Early vs Delayed
Sponsors
Otto Kranendonk Fonds - Dutch Association of Tropical Health (request pending)
Stanger Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Haemoglobin level | two months |
Secondary
| Measure | Time frame |
|---|---|
| Hyperviscosity syndrome | 1 day |
| Iron status | two months |
| hyperbilirubinaemia | 2 days |
Countries
South Africa
Outcome results
None listed