Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized Clinical Trial of Antioxidants to Prevent Preeclampsia and An Observational Cohort Study to Predict Preeclampsia
Brief 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).


Options:
A: Arm Label: micronutrient antioxidant; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: micronutrient antioxidant | Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Control | Intervention Type: DIETARY_SUPPLEMENT; Name: micronutrient antioxidant; Assigned to Arm(s): micronutrient antioxidant | Intervention Type: DIETARY_SUPPLEMENT; Name: Control; Assigned to Arm(s): Control
B: Arm Label: 5-methyltetrahydrofolate; Type: EXPERIMENTAL; Interventions: Dietary Supplement: 5-methyltetrahydrofolate | Arm Label: folic acid; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: folic Acid | Intervention Type: DIETARY_SUPPLEMENT; Name: 5-methyltetrahydrofolate; Assigned to Arm(s): 5-methyltetrahydrofolate | Intervention Type: DIETARY_SUPPLEMENT; Name: folic Acid; Assigned to Arm(s): folic acid
C: Arm Label: Dietary Supplement/Vitamins; Type: EXPERIMENTAL; Interventions: Drug: Dietary Supplement/Vitamins | Arm Label: Placebo for Vitamin C and Vitamin E; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo for Vitamin C and Vitamin E | Intervention Type: DRUG; Name: Dietary Supplement/Vitamins; Assigned to Arm(s): Dietary Supplement/Vitamins | Intervention Type: DRUG; Name: Placebo for Vitamin C and Vitamin E; Assigned to Arm(s): Placebo for Vitamin C and Vitamin E
D: Arm Label: Food supplement (FS); Type: EXPERIMENTAL; Interventions: Dietary Supplement: Food supplement enriched with multiple micronutrients | Arm Label: UNIMMAP; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: UNIMMAP - multiple micronutrients | Intervention Type: DIETARY_SUPPLEMENT; Name: UNIMMAP - multiple micronutrients; Assigned to Arm(s): UNIMMAP | Intervention Type: DIETARY_SUPPLEMENT; Name: Food supplement enriched with multiple micronutrients; Assigned to Arm(s): Food supplement (FS)

Answer: C