Condition category
Pregnancy and Childbirth
Date applied
22/11/2005
Date assigned
22/11/2005
Last edited
13/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

Sponsor information

Organisation

Liverpool School of Tropical Medicine (UK)

Sponsor details

Pembroke Place
Liverpool
L35QA
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17445128

Publication citations

  1. 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.

Additional files

Editorial Notes