Contact information
Type
Scientific
Primary contact
Dr P.F. Rheenen, van
ORCID ID
Contact details
Brinklaan 6
Groningen
9722 BC
Netherlands
p.f.vanrheenen@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR424
Study information
Scientific title
Acronym
Study hypothesis
Anaemia is recognized as an important cause of morbidity and mortality in under fives. When associated with iron deficiency, anaemia may impair mental and motor development. There are indications that with iron therapy anaemic children fail to catch up to non-anaemic children. Primary prevention of iron deficiency and malaria in young children could have substantive effect on reducing child mortality and morbidity.
Key strategies for the reduction of infant anaemia are: iron supplementation in pregnancy and infancy; iron-fortification of infant formula; chemoprophylaxis and prompt anti-malarial treatment in pregnancy and infancy; and use of insecticide-treated nets to reduce exposure to malaria. Combinations of the aforementioned strategies can synergistically improve anaemia. However, most have had limited success in developing countries due to financial, logistic and technical constraints.
In view of this there is interest in improving the iron status of infants by enhancing their red cell mass with late umbilical cord clamping. This intervention is said to increase haemoglobin (Hb) concentration by 2-3 months of age, especially in infants born to anaemic mothers. Whether this low cost delivery procedure is effective in reducing anaemia in infants from resource-poor countries that are malaria-endemic has never been evaluated.
Ethics approval
Received from local medical ethics committee
Study design
Randomised single blind active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Pregnancy
Intervention
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 the trial, and is usually done within 20 s after delivery. Mother-infant couples assigned to this procedure are thus considered the control group. In the DCC group the umbilical cord is clamped after the cord stops pulsating. The exact time is recorded by use of a stopwatch. A recently performed pilot study showed that cord pulsations normally cease after 3.5 minutes. Following vaginal birth the infant is placed between the legs of the mother (approximately 15 cm below the vaginal introitus), dried, and wrapped in a warm towel.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Post-treatment Hb level in relation to pre-treatment values and the proportion of non-anaemic infants at two, four and six months after birth.
Secondary outcome measures
Possible side effects of DCC in infants (Packed Cell Volume [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).
Overall trial start date
01/05/2004
Overall trial end date
31/01/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Full term pregnant women delivering in Mpongwe Mission Hospital are candidates for inclusion in the study.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
91
Participant 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.
Recruitment start date
01/05/2004
Recruitment end date
31/01/2005
Locations
Countries of recruitment
Zambia
Trial participating centre
Brinklaan 6
Groningen
9722 BC
Netherlands
Funders
Funder type
Other
Funder name
Liverpool-Amsterdam Cooperation Fund
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17445128
Publication citations
-
Results
van Rheenen P, de Moor L, Eschbach S, de Grooth H, Brabin B, Delayed cord clamping and haemoglobin levels in infancy: a randomised controlled trial in term babies., Trop. Med. Int. Health, 2007, 12, 5, 603-616, doi: 10.1111/j.1365-3156.2007.01835.x.