The study takes place in Mpongwe District, a rural region of the Copperbelt Province in Zambia, approximately 1000m above sea level. Malaria transmission in this area is holoendemic. The rainy season, which is associated with peak malaria transmission, occurs from November to April.
Conditions
Interventions
Pregnant women are randomised to either the intervention of delayed cord clamping (DCC) or immediate cord clamping (ICC). ICC is the routine standard of care in Mpongwe Mission Hospital at the time of
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: Full term pregnant women delivering in Mpongwe Mission Hospital are candidates for inclusion in the study.
Exclusion criteria
Exclusion criteria: 1. Twin pregnancy; 2. History of post partum haemorrhage (PPH) > 500 ml; 3. Gestational diabetes; 4. (Pre)eclampsia; 5. Placental separation before delivery; 6. Caesarean section; 7. Tight nuchal cord; 8. Need for neonatal resuscitation; 9. Major congenital abnormalities (e.g. neural tube defects). Criteria 1-4 are applied before randomisation. Criteria 5-9 can only be assessed after randomisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints with respect to haematological status are the post-treatment Hb level in relation to pre-treatment values and the proportion of non-anaemic infants at respectively two, four and six months after birth. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures include possible side effects of DCC in infants (PCV changes 1 day postpartum; clinical signs of hyperviscosity syndrome and hyperbilirubinaemia) and mothers (Hb level one day after delivery in relation to antenatal values). | — |
Contacts
Public ContactP.F. Rheenen, van
Brinklaan 6
Outcome results
None listed