Study prematurely discont'd 20-Apr-2006 after interim analysis suggested sample size could be reduced without losing power. No safety concerns led to decision.

To determine the efficacy and safety of sildenafil citrate in the treatment of established pre-eclampsia

Inclusion Criteria:

• Subjects with pre-eclampsia defined as new hypertension with a diastolic BP of > or = 90 mmHg on two occasions separated by at least 4 hrs arising after 20 weeks of pregnancy, associated with >500 mg/24 hr proteinuria. Subjects with pre-existing hypertension (on treatment) need only fulfill proteinuria requirement.
• Gestational age 24-34 w
• Singleton pregnancy

Exclusion Criteria:

• Where urgent delivery is indicated
• Where the fetus is suspected to have a structural or chromosomal abnormality