At a glance
ClinicalIndex Comparison Record- ✓Gestational age 9-16 weeks at randomization
- ✓Singleton pregnancy
- ✓Nulliparous (no prior deliveries)
- ✕Blood pressure ≥135/85 mmHg
- ✕Proteinuria on urinalysis
- ✕Current or prior use of antihypertensive medications or diuretics
- ✕Pregestational diabetes (Type 1 or Type 2)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Clinical Trial of Antioxidants to Prevent Preeclampsia and An Observational Cohort Study to Predict Preeclampsia
In Brief
A Phase 3 clinical trial evaluating Dietary Supplement/Vitamins and Placebo for Vitamin C and Vitamin E for Preeclampsia. Completed, enrolled 10,154 participants across 16 sites.
Detailed 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).
Study Details
Timeline
Interventions
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.