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
Secondary identifying numbers	G9701680

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Lelia Duley
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 study start date	01/01/1998
Completion date	31/01/2005

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	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

MAGPIE Trial Co-ordinating Centre

Oxford
OX3 7LF
United Kingdom

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone	+44 (0)20 7636 5422
Email	clinical.trial@headoffice.mrc.ac.uk
Website	http://www.mrc.ac.uk

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	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