Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS)

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).

Conditions

• Preeclampsia

Interventions

DRUG

Dietary Supplement/Vitamins

Vitamin C (1000 mg) and Vitamin E (400 IU) per capsule, two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery.

DRUG

Placebo for Vitamin C and Vitamin E

Placebo two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  collaborator NIH

• The George Washington University Biostatistics Center

  lead OTHER

Principal Investigators

• Menachem Miodovnik, MD · NICHD Project Scientist

• Rebecca Clifton, Ph.D. · George Washington University Biostatistics Center

• James M Roberts, MD · University of Pittsburgh - Magee Womens

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2003-06-30

Primary Completion

2008-10-31

Completion

2009-01-31

Countries

• United States

Study Locations