University Hospital Advanced Age Pregnant Cohort
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 22,000
- 试验地点
- 9
- 主要终点
- Incidence of major gestational complications and adverse pregnancy outcomes in pregnant women with the advanced age, for a singleton or twin and higher order multiple gestation
研究概览
简要总结
The University Hospital Advanced Age Pregnant (UNIHOPE) Cohort is the major part of the National Key Research and Development Program on Reproductive Health & Major Birth Defects Control and Prevention Project, which is funded by the Ministry of Science and Technology of China. The Project is led by Prof. Zhao Yangyu, from the Department of Gynecology & Obstetrics, Peking University Third Hospital, and the UNIHOPE cohort is led by Prof. Jian-meng Liu, the Co-PI of the Project.
详细描述
The UNIHOPE Cohort is set up to provide comprehensive evidence for the prevention and treatment of gestational complications in pregnant women with advanced maternal age, and therefore, to meet the growing clinical challenges of increasing pregnant women with advanced age in the two-child era. The UNIHOPE Cohort is planning to recruit 22,000 pregnant women aged ≥35 years from 9 large obstetrical center of major University-affiliated Hospitals across China, between July 2016 and December 2020. All women will be enrolled prior to 14 wks of gestation, followed up at 24-28 wks, 32-34 wks of gestation, delivery, and 42 days postpartum. Data including demographics, medical history, reproductive history, prenatal health care, gestational complications, and pregnancy and birth outcomes will be collected via electronic data capture system. Venous blood of the pregnant women will be collected at enrollment and each follow-up visit during pregnancy, and placental tissue, cord blood and hair of the newborn will also be collected.
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
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female aged ≥ 35 years
- •Less than 14 gestational weeks
- •Planning to receive prenatal healthcare and delivery service at the study hospital
排除标准
- •Inability to provide informed consent
- •Women with mental disorders
结局指标
主要结局
Incidence of major gestational complications and adverse pregnancy outcomes in pregnant women with the advanced age, for a singleton or twin and higher order multiple gestation
时间窗: At enrollment, 24-28 weeks, 32-34 weeks of gestation, delivery, and 42 days postpartum
Gestational diabetes mellitus, hypertensive disease of pregnancy, uterine scar pregnancy, placenta previa, preterm delivery, postpartum hemorrhage, low birth weight, spontaneous abortion, stillbirth, perinatal death
次要结局
- Birth length(At delivery)
- Maternal death(At 24-28 weeks, 32-34 weeks of gestation, delivery, and 42 days postpartum)
- The rate of cesarean delivery(At delivery)
- Gestational duration(At enrollment, delivery)
- Birth weight(At delivery)
研究者
Jianmeng Liu
Prof.
Peking University