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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN86938761
Enrollment
10141
Registered
2000-10-25
Start date
1998-01-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-eclampsia Pregnancy and Childbirth Pre-eclampsia

Interventions

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

Sponsors

Medical Research Council (MRC) (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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)

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
1. Eclampsia 2. Death of the baby.

Secondary

MeasureTime frame
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

Countries

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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026