Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS)
Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
Summary
Preeclampsia is one of the most common complications of pregnancy and is characterized by
high blood pressure and protein in the urine. This can cause problems in the second half of
pregnancy for both the mother and fetus. This study of preeclampsia consists of two parts: 1)
a randomized, placebo controlled, multicenter clinical trial of 10,000 low-risk nulliparous
women between 9 and 16 weeks gestation and 2) an observational, cohort study of 4,000
patients between 9 and 12 weeks gestation who are also enrolled in the trial.
Subjects in both parts will receive either 1000 mg of vitamin C and 400 IU of vitamin E or
matching placebo daily. The purpose of the randomized, clinical trial is to find out if high
doses of vitamin C and E will reduce the risk of preeclampsia and other problems associated
with the disease. The study will also evaluate the safety of antioxidant therapy for mother
and infant. Patients will be seen monthly to receive their supply of study drug, to have
weight and blood pressure recorded, to have urine protein measured, and to assess any side
effects. At two visits, blood and urine will be collected.
The observational, cohort study will prospectively measure potential biochemical and
biophysical markers that might predict preeclampsia. These patients will have additional
procedures including uterine artery Doppler and blood drawn for a complete blood count (CBC).
Phase:
Phase 3
Details
Lead Sponsor:
The George Washington University Biostatistics Center
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Heart, Lung, and Blood Institute (NHLBI)
Treatments:
alpha-Tocopherol Antioxidants Ascorbic Acid Tocopherols Tocotrienols Vitamin E Vitamins