Sildenafil Citrate for the Treatment of Established Pre-Eclampsia

A Randomised, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study to Evaluate the Efficacy, Safety and Toleration of Oral Sildenafil Citrate Administered in the Dose Range of 20 - 80 Mg TID for the Treatment of Pre-Eclampsia. (PET)

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