Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS)
Completed · Phase 3 · Has a placebo group
Conditions studied: Preeclampsia
In brief
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).
Key facts
- Study ID
- NCT00135707
- Run by
- The George Washington University Biostatistics Center
- People needed
- 10154
- Starts
- 2003-06-01
- Expected to finish
- 2009-01-01
- Last updated by the study team
- 2019-02-21
Who can join
Age: any. Sex: female. Healthy volunteers: accepted.
Where it is running
- University of Alabama - Birmingham — Birmingham, Alabama, United States
- Northwestern University — Chicago, Illinois, United States
- Wayne State University — Detroit, Michigan, United States
- Columbia University — New York, New York, United States
- University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
- Wake Forest University School of Medicine — Winston-Salem, North Carolina, United States
- Case Western University — Cleveland, Ohio, United States
- Ohio State University — Columbus, Ohio, United States
- Oregon Health and Sciences University — Portland, Oregon, United States
- Drexel University — Philadelphia, Pennsylvania, United States
- University of Pittsburgh Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
- Brown University — Providence, Rhode Island, United States
- University of Texas - Southwest — Dallas, Texas, United States
- University of Texas Medical Branch — Galveston, Texas, United States
- University of Texas - Houston — Houston, Texas, United States
- University of Utah Medical Center — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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