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临床试验/NCT05727085
NCT05727085招募中不适用

Cohort of Twin Pregnancy and the Offspring

Fudan University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Protein profiles in placentas of twin pregnancy measured by tandem mass tags quantification.

研究概览

简要总结

Twin pregnancy increases the risk of maternal and fetal complications, which include gestational hypertension, premature labor, twin-to-twin transfusion syndrome, intrauterine growth restriction, anemia, amniotic fluid abnormalities. Comprehensively understanding the molecular mechanisms of the disease and identification of markers contribute to development of novel therapeutic approaches. In addition, the twin pregnancy, especially the monochorionic, is an essential model of "experiments of nature". This model can be applied to distinguish the epigenetic differences of twins in utero and after birth in the same genomic context. The aim of the study is to constitute a prospective cohort of twin pregnancies and the offspring.

详细描述

Data are collected regarding the pregnancy data of the mother, and mental, physical and sociodemographic information of the offspring. The periods span from diagnosis of twins to 3 years old of the offspring. Biological samples would be collected including maternal blood, placental tissues, cord blood, urine, and stool from the pregnant women or the offspring at the specific time.

The total estimated duration of the study is 6 years, of which the first 2.5 years will correspond to the recruitment period of the participants.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Maternal age >18 years old.
  • Twin pregnancy.

排除标准

  • Fetal chromosomal or congenital abnormalities.
  • Stillbirth.

结局指标

主要结局

Protein profiles in placentas of twin pregnancy measured by tandem mass tags quantification.

时间窗: Immediately after delivery

Levels of proteins in placentas of twin pregnancy.

Lipid profiles in placentas of twin pregnancy measured by lipidomic analysis

时间窗: Immediately after delivery

Lipid profiles in placentas of twin pregnancy.

Global DNA methylation in placentas of twin pregnancy measured by whole-genome bisulfite sequencing

时间窗: Immediately after delivery

Global DNA methylation levels in placentas of twin pregnancy.

Metabolite profiles in placentas of twin pregnancy measured by metabolomics

时间窗: Immediately after delivery

Metabolite profiles in placentas of twin pregnancy.

Predictive lipid markers of maternal and fetal complications in maternal blood measured by lipidomic analysis

时间窗: From confirmation of pregnancy to 42 days postpartum

Levels of specific lipids in maternal blood.

Post-translation modification of proteins in placentas of twin pregnancy measured by Integrative use of phosphoproteomics, ubiquitylproteomics and acetylproteomics.

时间窗: Immediately after delivery

Post-translational levels of proteins in placentas of twin pregnancy.

The incidence of maternal and fetal complications

时间窗: From confirmation of pregnancy to 42 days postpartum

The incidence of preeclampsia, gestational diabetes mellitus, premature delivery, postpartum hemorrhage, twin to twin transfusion syndrome, selective intrauterine growth restriction.

RNA profiles in placentas of twin pregnancy measured by RNA-sequencing

时间窗: Immediately after delivery

Levels of placental RNA expression.

Predictive protein markers of maternal and fetal complications in maternal blood measured by tandem mass tags quantification

时间窗: From confirmation of pregnancy to 42 days postpartum

Levels of specific proteins in maternal blood.

Predictive RNA markers of maternal and fetal complications in maternal blood measured by RNA-sequencing

时间窗: From confirmation of pregnancy to 42 days postpartum

Levels of specific RNAs in maternal blood.

Predictive metabolite markers of maternal and fetal complications in maternal blood measured by metabolomics

时间窗: From confirmation of pregnancy to 42 days postpartum

Levels of specific metabolites in maternal blood.

次要结局

  • The incidence of long term maternal complications(Three years after delivery)
  • The level of twin Neurodevelopment assessed by Gesell Developmental Schedules(Age at 3 years of the offspring)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yu Xiong

Clinical Professor

Fudan University

研究点 (1)

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