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临床试验/NCT02441335
NCT02441335已完成不适用

CellulaR Injury and Preterm Birth

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 705 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
705
试验地点
1
主要终点
Biogenetics

研究概览

简要总结

The goal of this study is to examine how cellular dysfunction can lead to preterm birth. Women with singleton pregnancies with spontaneous preterm labor, preterm premature rupture of membranes, and cervical insufficiency (20 to 36-6/7 weeks gestation), and term deliveries (greater than 38 weeks) will be enrolled. Medical/obstetric history and pregnancy outcomes will be recorded. Maternal blood, urine and cervical cells (enrollment); cord blood and placental biopsy (delivery) will be collected.

详细描述

Despite improvements in prenatal care, preterm birth (PTB) remains a leading contributor to perinatal morbidity and mortality. Several genetic and environmental factors have been associated with spontaneous preterm birth, but the pathways by which these factors induce preterm delivery have not been defined. The March of Dimes CPR at the University of Pennsylvania was created to help elucidate the pathogenesis of preterm birth by bringing together a diverse team of investigators with expertise in preterm birth, cellular metabolism, genetics, mitochondrial functional analyses, genome, epigenome, and transcriptome profiling, integrated bioinformatics analyses, and microbiome research. The center will focus on addressing the interactions between bioenergetics, genetics, microbiome, abnormal cervical remodeling and placental dysfunction. Each one of these factors will be studied independently and in relation to the other factors. In order to study metabolic processes in relation to spontaneous PTB, a prospective case-control study will be performed. This study will involve women with singleton pregnancies with spontaneous preterm labor (PTL), preterm premature rupture of membranes (PPROM), and cervical insufficiency, between 20-0/7 and 36-6/7 weeks gestational age (cases), and women with term deliveries (38 to 41 weeks gestation, controls). The investigators will obtain information regarding the patients' pertinent past medical and obstetric histories, and the following specimens will be collected: maternal blood, maternal urine, and cervical epithelial cells at enrollment; and umbilical cord blood and placental biopsies at delivery. We will follow and record each of these patients' pregnancy outcomes.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 18-45 years of age
  • Singleton pregnancy between 20 0/7 and 36 6/7 weeks gestational age who is admitted with preterm labor or cervical insufficiency (greater than 2 cm dilation) or Preterm Premature Rupture of Membranes

排除标准

  • Multiple gestation
  • Fetal chromosomal abnormality
  • Major fetal anomaly
  • Intra-uterine fetal demise
  • Gestational hypertension/preeclampsia
  • Inclusion Criteria:
  • 18-45 years of age
  • Singleton pregnancy that delivers at term (38 to 41 weeks gestational age)
  • Admitted to the hospital with spontaneous labor (regular contractions, cervical dilation) or spontaneous rupture of membranes
  • Exclusion Criteria:
  • Multiple gestation
  • Fetal chromosomal abnormality
  • Major fetal anomaly
  • Intra-uterine fetal demise
  • Intra-uterine growth restriction
  • Gestational hypertension/preeclampsia
  • Clinical chorioaminionitis
  • Induction of labor
  • Elective c-section

结局指标

主要结局

Biogenetics

时间窗: 5 years

The role of biogenetics in pregnancy and what are the perturbations in cell metabolism that lead to spontaneous preterm birth.

Microbiome

时间窗: 5 years

The interactions between the microbiome (oral, gut, cervicovaginal, and placental) and host metabolic function in pregnancy.

Cervical remodeling

时间窗: 5 years

How the interactions between cell metabolism and the microbiome influence cervical remodeling and placental function leading to spontaneous preterm delivery.

Genetics and Environmental factors

时间窗: 5 years

How genetic and environmental factors influence the metabolic function of reproductive tissues leading to spontaneous preterm delivery.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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CellulaR Injury and Preterm Birth | 临床试验