Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS)

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

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

Criteria

RCT Inclusion Criteria:

• Gestational age 9 -16 weeks

• Singleton pregnancy

• Nulliparous

Observational Inclusion Criteria:

• Women randomized to the RCT

• Gestational age 9 - 12 wks

Exclusion Criteria RCT and Observational:

• BP >= 135/85

• Proteinuria

• History or current use of anti-hypertensive medication or diuretics

• Use of vitamins C > 150 mg and/or E > 75 IU per day

• Pregestational diabetes

• Current pregnancy is a result of in vitro fertilization

• Regular use of platelet active drugs or non-steroidal anti-inflammatory drugs (NSAIDS)

• Known fetal abnormalities

• Documented uterine bleeding within a week of screening

• Uterine malformations

• History of medical complications

• Illicit drug or alcohol abuse during current pregnancy

• Intent to deliver elsewhere

• Participating in another interventional study