Condition category
Pregnancy and Childbirth
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
27/09/2011
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 N Bhandal

ORCID ID

Contact details

Nuffield Department of Anaesthesia
John Radcliffe
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 221590

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0176127659

Study information

Scientific title

Acronym

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Intravenous iron sucrose, oral iron sulphate

Primary outcome measures

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 trial start date

22/07/2003

Overall trial end date

28/02/2004

Reason abandoned

Eligibility

Participant inclusion criteria

50 patients

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

50

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

United Kingdom

Trial participating centre

Nuffield Department of Anaesthesia
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Oxford Radcliffe Hospitals NHS Trust (UK)

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

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/17004982

Publication citations

  1. Results

    Bhandal N, Russell R, Intravenous versus oral iron therapy for postpartum anaemia., BJOG, 2006, 113, 11, 1248-1252, doi: 10.1111/j.1471-0528.2006.01062.x.

Additional files

Editorial Notes