Condition category
Pregnancy and Childbirth
Date applied
25/10/2000
Date assigned
25/10/2000
Last edited
09/07/2014
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 Lelia Duley

ORCID ID

Contact details

MAGPIE Trial Co-ordinating Centre
Institute of Health Sciences
Old Road
Headington
Oxford
OX3 7LF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G9701680

Study information

Scientific title

Acronym

MAGPIE

Study hypothesis

To determine the effect of magnesium sulphate when used for women with pre-eclampsia on the risk of eclampsia and perinatal death. In addition, to determine the effects of other measures of important morbidity and on use of health services resources.

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

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Pre-eclampsia

Intervention

Magnesium sulphate/placebo.
Follow-up: until discharge following delivery. Four year follow-up of the children is planned.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Eclampsia
2. Death of the baby.

Secondary outcome measures

1. Maternal death
2. Serious maternal morbidity
3. Labour and delivery outcomes
4. Use of maternal health services
5. Serious neonatal morbidity
6. Use of neonatal health services

Overall trial start date

01/01/1998

Overall trial end date

31/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Not delivered, or delivered within the last 24 hours
2. Blood pressure today is ≥90 mmHg diastolic or ≥140 mmHg systolic, on at least two occasions
3. Proteinuria of at least 1+
4. There is clinical uncertainty about whether magnesium sulphate would be beneficial (factors likely to influence this uncertainty are the presence of any of the following: hypereflexia, frontal headache, abnormal liver function or coagulation, and epigastric tenderness)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

10141

Participant exclusion criteria

The woman does not wish to be randomised, for whatever reason/the attending clinician believes magnesium sulphate should either be given or withheld/hypersensitivity to magnesium/renal failure (women who have renal impairment may be randomised, but the volume of allocated treatment should be halved for each dose)/hepatic coma if risk of renal failure/myaesthenia gravis.

Recruitment start date

01/01/1998

Recruitment end date

31/01/2005

Locations

Countries of recruitment

Albania, Argentina, Australia, Bangladesh, Brazil, Colombia, Cuba, Egypt, Ghana, India, Malawi, Nigeria, Pakistan, Sierra Leone, Singapore, South Africa, United States of America, Zimbabwe

Trial participating centre

MAGPIE Trial Co-ordinating Centre
Oxford
OX3 7LF
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

2002 results in: http://www.ncbi.nlm.nih.gov/pubmed/12057549
2004 results in: http://www.ncbi.nlm.nih.gov/pubmed/15113445
2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17166220
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19366459

Publication citations

  1. Results

    Altman D, Carroli G, Duley L, Farrell B, Moodley J, Neilson J, Smith D, , Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial., Lancet, 2002, 359, 9321, 1877-1890.

  2. Results

    , , The Magpie Trial follow up study: outcome after discharge from hospital for women and children recruited to a trial comparing magnesium sulphate with placebo for pre-eclampsia [ISRCTN86938761]., BMC Pregnancy Childbirth, 2004, 4, 1, 5, doi: 10.1186/1471-2393-4-5.

  3. Results

    The Magpie Trial: a randomised trial comparing magnesium sulphate with placebo for pre-eclampsia. Outcome for women at 2 years., BJOG, 2007, 114, 3, 300-309, doi: 10.1111/j.1471-0528.2006.01166.x.

  4. Results

    Smyth RM, Spark P, Armstrong N, Duley L, Magpie Trial in the UK: methods and additional data for women and children at 2 years following pregnancy complicated by pre-eclampsia., BMC Pregnancy Childbirth, 2009, 9, 15, doi: 10.1186/1471-2393-9-15.

Additional files

Editorial Notes