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
Scientific
MAGPIE Trial Co-ordinating Centre
Institute of Health Sciences
Old Road
Headington
Oxford
OX3 7LF
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study acronym | MAGPIE |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pre-eclampsia |
| Intervention | Magnesium sulphate/placebo. Follow-up: until discharge following delivery. Four year follow-up of the children is planned. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Eclampsia |
| Key secondary outcome measure(s) |
1. Maternal death |
| Completion date | 31/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 10141 |
| Key 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) |
| Key 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. |
| Date of first enrolment | 01/01/1998 |
| Date of final enrolment | 31/01/2005 |
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
OX3 7LF
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 | 01/06/2002 | 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 |