Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS)
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Intervention: Dietary Supplement/Vitamins; Placebo for Vitamin C and Vitamin E
Intervention description: Vitamin C (1000 mg) and Vitamin E (400 IU) per capsule, two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery.; Placebo two capsules daily between randomization (at 9 - 16 weeks gestation) up to delivery.
Intervention MeSH terms: Vitamins; Ascorbic Acid; Vitamin E; alpha-Tocopherol
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 10154.0
Sex: Female
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Antioxidants; Preeclampsia; Pregnancy; Hypertension

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).
    

Eligibility 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