Please select the outcome measures that correspond 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: Preeclampsia (40 weeks); Preeclampsia (9 months)
B: ongoing pregnancy on the 20th week of gestational age (20th week of gestational age)
C: Composite of Pregnancy-associated Hypertension and Serious Adverse Outcomes in the Mother or Fetus or Neonate (20 weeks through discharge following delivery); Severe Hypertension (20 weeks through discharge following delivery); Severe or Mild Pregnancy-associated Hypertension With Elevated Liver Enzyme Levels (20 weeks through discharge following delivery); Severe or Mild Pregnancy-associated Hypertension With Thrombocytopenia (20 weeks through discharge following delivery); Severe or Mild Pregnancy-associated Hypertension With an Elevated Serum Creatinine Level (20 weeks through discharge following delivery); Severe or Mild Pregnancy-associated Hypertension With an Eclamptic Seizure (20 weeks through discharge following delivery); Severe or Mild Pregnancy-associated Hypertension With an Indicated Preterm Birth Before 32 Weeks of Gestation Owing to Hypertension-related Disorders (20 weeks through discharge following delivery); Severe or Mild Pregnancy-associated Hypertension With a Fetus That Was Small for Gestational Age (Below the 3rd Percentile) Adjusted for Sex and Race or Ethnic Group (20 weeks through discharge following delivery); Severe or Mild Pregnancy-associated Hypertension With a Fetal Death After 20 Weeks of Gestation or Neonatal Death (20 weeks through discharge or prior to discharge following delivery admission)
D: Weight, length and Rohrer index at birth, and gestational duration in singleton pregnancies. (At birth); Mortality, morbidity and growth during the first year of life (Monthly during infancy)

Answer: C