COMBINED ANTIOXIDANT AND PREECLAMPSIA PREDICTION STUDIES (CAPPS)

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Preeclampsia is one of the most common complications of pregnancy and remains a major cause of fetal and maternal morbidity and mortality. Recent clinical studies have suggested that daily antioxidant therapy may be of value in preventing preeclampsia and its associated complications. The purpose of this randomized clinical trial is to evaluate the effects of antioxidant therapy in preventing serious complications associated with pregnancy related hypertension in low risk, nulliparous women who begin treatment 9-16 weeks gestation. This study will also evaluate the safety of antioxidant therapy to mother and infant. The study is a randomized, placebo controlled multi-center clinical trial of 10,000 nulliparous women between 9 weeks 0 days and 16 weeks 6 days gestation. Women will be randomized to one of two groups: (1) Vitamin C (1000 mg) and Vitamin E (400 IU) or (2) matching placebo. Each patient will take two capsules daily. If an ultrasound examination has not been performed, one must be arranged prior to randomization for gestational age estimation. Each patient will be given a 7-day supply of placebo capsule in a single-blind manner. The patient must return within 14 days for a compliance check. Each woman will be seen monthly. Blood and urine will be collected at various visits. Blood from the umbilical cord will be collected after delivery. The neonate will have anthropometric obtained prior to discharge from the hospital