Cord Clamping Study - Mpongwe (Zambia)
| ISRCTN | ISRCTN48735857 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48735857 |
| Secondary identifying numbers | NTR424 |
- Submission date
- 22/11/2005
- Registration date
- 22/11/2005
- Last edited
- 13/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr P.F. Rheenen, van
Scientific
Scientific
Brinklaan 6
Groningen
9722 BC
Netherlands
| p.f.vanrheenen@gmail.com |
Study information
| Study design | Randomised single blind active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | |
| Study objectives | 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(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2004 |
| Completion date | 31/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 91 |
| Key inclusion criteria | Full term pregnant women delivering in Mpongwe Mission Hospital are candidates for inclusion in the study. |
| Key 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. |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 31/01/2005 |
Locations
Countries of recruitment
- Netherlands
- Zambia
Study participating centre
Brinklaan 6
Groningen
9722 BC
Netherlands
9722 BC
Netherlands
Sponsor information
Liverpool School of Tropical Medicine (UK)
University/education
University/education
Pembroke Place
Liverpool
L35QA
England
United Kingdom
"ROR" |
https://ror.org/03svjbs84 |
|---|
Funders
Funder type
Other
Liverpool-Amsterdam Cooperation Fund
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2007 | Yes | No |
