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

Completed

Conditions: Pre-eclampsia
Pregnancy and Childbirth

Registration Number: ISRCTN86938761

Lead Sponsor: Medical Research Council (MRC) (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 10141

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Eclampsia<br>2. Death of the baby.

Secondary Outcome Measures

Name	Time	Method
1. Maternal death<br>2. Serious maternal morbidity<br>3. Labour and delivery outcomes<br>4. Use of maternal health services<br>5. Serious neonatal morbidity<br>6. Use of neonatal health services