University Hospital Advanced Age Pregnant Cohort
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 22,000
- Locations
- 9
- Primary Endpoint
- 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
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 35 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Female aged ≥ 35 years
- •Less than 14 gestational weeks
- •Planning to receive prenatal healthcare and delivery service at the study hospital
Exclusion Criteria
- •Inability to provide informed consent
- •Women with mental disorders
Outcomes
Primary Outcomes
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
Time Frame: 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
Secondary Outcomes
- 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)
Investigators
Jianmeng Liu
Prof.
Peking University