COMBINED ANTIOXIDANT AND PREECLAMPSIA PREDICTION STUDIES (CAPPS)

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。先兆子痫是最常见的妊娠并发症之一，并且仍然是胎儿和母亲发病率和死亡率的主要原因。最近的临床研究表明，每日抗氧化治疗可能对预防先兆子痫及其相关并发症有价值。 本随机临床试验的目的是评价抗氧化治疗在预防妊娠高血压相关严重并发症中的作用，这些并发症发生在妊娠开始治疗的9-16周的低风险、未经产妇女中。本研究还将评估抗氧化治疗对母亲和婴儿的安全性。 该研究是一项随机、安慰剂对照的多中心临床试验，纳入了10，000名妊娠9周0天和16周6天之间的未经产妇女。女性将被随机分为两组：（1）维生素C（1000 mg）和维生素E（400 IU）或（2）匹配的安慰剂。 每位患者每天服用2粒胶囊。 如果未进行超声检查，则必须在随机化前安排超声检查，以估计胎龄。每例患者将以单盲方式接受为期7天的安慰剂胶囊给药。患者必须在14天内返回进行依从性检查。 每个女人每月都会被看到。将在不同访视时采集血液和尿液。脐带血将在分娩后收集。新生儿出院前将进行人体测量

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