Iron therapy for postpartum anaemia: intravenous versus oral administration
| ISRCTN | ISRCTN35112104 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35112104 |
| Protocol serial number | N0176127659 |
| Sponsor | Department of Health |
| Funder | Oxford Radcliffe Hospitals NHS Trust (UK) |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Intravenous iron sucrose, oral iron sulphate |
| Primary outcome measure(s) |
Haemoglobin levels on day 5 post caesarean section and at 6 week check - Questionnaire to assess symptoms in each group. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 28/02/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 50 |
| Key inclusion criteria | 50 patients |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 22/07/2003 |
| Date of final enrolment | 28/02/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Nuffield Department of Anaesthesia
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
