Please select the eligibility criteria 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: Inclusion Criteria:

* pregnant women with 8-12 weeks of gestation

Exclusion Criteria:

* known multiple pregnancy
* known fetal anomaly
* known thrombophilia
* known infections and mola hydatidosa
* chronic renal failure
* uncontrolled hypertension
* known placental abnormalities
* documented uterine bleeding within a week of screening
* uterine malformation
* history of medical and metabolic complication such as heart disease or diabetes
B: Inclusion criteria:

* Willing to participate in the study and filling out the informed consent form,
* History of 3 or more idiopathic abortion,
* the last abortion should be more than 6 months ago,
* no history of consumption of folate supplements or high folate containing foods during last 6 months,
* All previous abortions should be idiopathic without any anatomic, cytologic, hormonal, septic pathologic finding,
* no special diets

Exclusion Criteria:

* elective or induced abortion, molar or ectopic pregnancies,
* presence of any malignancy, chromosomal abnormality, uterine abnormality, Thyroid, kidney, or liver dysfunction, Glucose intolerance, seizure,
* Alcohol or drug abuse,
* Taking any drug affecting homocystein metabolism,
* not following the study protocol.
C: 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
D: Inclusion Criteria:

* All the women of child-bearing age (15-44 years) living in the study area (4 100) will be visited monthly to assess early pregnancy and will be invited to participate in the trial.

Exclusion Criteria:

* planning to move outside the district within the 2 years following the start of the trial.
* regularly using a contraceptive method.
* already pregnant at the start of the trial.

Answer: C