Magnesium sulphate for the treatment of pre-eclampsia: a trial to evaluate the effects on women and babies

ISRCTN ISRCTN86938761
DOI https://doi.org/10.1186/ISRCTN86938761
Protocol serial number G9701680
Sponsor Medical Research Council (MRC) (UK)
Funder Medical Research Council (MRC) (UK)
Submission date
25/10/2000
Registration date
25/10/2000
Last edited
09/07/2014
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 Lelia Duley
Scientific

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

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific title
Study acronymMAGPIE
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedPre-eclampsia
InterventionMagnesium sulphate/placebo.
Follow-up: until discharge following delivery. Four year follow-up of the children is planned.
Intervention typeOther
Primary outcome measure(s)

1. Eclampsia
2. Death of the baby.

Key secondary outcome measure(s)

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

Completion date31/01/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target sample size at registration10141
Key inclusion criteria1. 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)
Key exclusion criteriaThe 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.
Date of first enrolment01/01/1998
Date of final enrolment31/01/2005

Locations

Countries of recruitment

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

Study participating centre

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

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/06/2002 Yes No
Results article results 08/03/2004 Yes No
Results article results 01/03/2007 Yes No
Results article results 14/04/2009 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes