Iron therapy for postpartum anaemia: intravenous versus oral administration
| ISRCTN | ISRCTN35112104 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35112104 |
| Secondary identifying numbers | N0176127659 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 27/09/2011
- 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
Not provided at time of registration
Contact information
Dr N Bhandal
Scientific
Scientific
Nuffield Department of Anaesthesia
John Radcliffe
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 221590 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study hypothesis | After pregnancy anaemia occurs in up to 30% of women. This is usually treated with iron tablets but in severe cases blood transfusion may be required. Intravenous iron may also be used to replenish stores. The aim of this study is to assess if a short course of intravenous iron sucrose is more effective than oral iron sulphate in the treatment of postpartum anaemia. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Postpartum anaemia |
| Intervention | Randomised controlled trial: short course of intravenous iron sucrose vs oral iron sulphate in the treatment of postpartum anaemia. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Intravenous iron sucrose, oral iron sulphate |
| Primary outcome measure | Haemoglobin levels on day 5 post caesarean section and at 6 week check - Questionnaire to assess symptoms in each group. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 22/07/2003 |
| Overall study end date | 28/02/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 50 |
| Participant inclusion criteria | 50 patients |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 22/07/2003 |
| Recruitment end date | 28/02/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Nuffield Department of Anaesthesia
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Oxford Radcliffe Hospitals NHS Trust (UK)
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 | 01/11/2006 | Yes | No |
