Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS)
Combined Antioxidant and Preeclampsia Prediction Studies (CAPPS)
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).
A Randomized, Clinical Trial of Antioxidants to Prevent Preeclampsia:

 Preeclampsia is the leading cause of maternal morbidity, as well as perinatal morbidity and
 mortality. Once the diagnosis has been established, therapy other than delivery has not been
 successful except to prolong pregnancy minimally (at some risk to mother and infant).
 Prevention efforts to reduce or eliminate preeclampsia are directed at the pathophysiology of
 the disorder prior to clinically evident preeclampsia and before irreversible changes have
 occurred.

 This double-masked, placebo-controlled trial of 10,000 subjects is designed to evaluate the
 effects of antioxidant therapy in preventing serious complications associated with
 pregnancy-related hypertension in low risk, nulliparous women who begin treatment at 9-16
 weeks gestation. The hypothesis being tested is that antioxidant therapy initiated prior to
 16 weeks gestation will reduce the frequency of serious maternal and infant complications
 associated with pregnancy-related hypertension.

 After randomization, subjects will receive either 1000 mg of vitamin C and 400 IU of vitamin
 E or matching placebo daily. They will be seen for monthly pill counts and to assess side
 effects, weight, blood pressure, and urine for protein. Blood and urine are collected at 24
 and 32 weeks' gestation.

 An Observational Cohort Study to Predict Preeclampsia:

 A prospective, cohort study has been designed to complement the randomized, controlled, trial
 (RCT) and will test various biochemical and biophysical markers for ability to predict
 preeclampsia in 4,000 of the women who are enrolled in the RCT and are between 9 and 12 weeks
 gestation. These subjects will have additional procedures including a CBC and uterine artery
 Doppler.
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