Clinical trial NCT03220750: University Hospital Advanced Age Pregnant Cohort
Official title: University Hospital Advanced Age Pregnant Cohort
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Maternal Age Pregnancy
High Risk Pregnancy
Perinatal Death
Maternal Death
Various Pregnancy Complications
Stillbirth and Fetal Death
Abortion, Spontaneous
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: Peking University First Hospital
name: Obstetrics & Gynecology Hospital of Fudan University
name: Shengjing Hospital
name: The Third Affiliated Hospital of Guangzhou Medical University
name: West China Second University Hospital
name: First Affiliated Hospital of Chongqing Medical University
name: Beijing Obstetrics and Gynecology Hospital
name: Tongji Hospital
name: Shenzhen Institutes of Advanced Technology ,Chinese Academy of Sciences
First posted: 2017-07-18
Enrollment: 22000
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The UNIHOPE Cohort is a prospective cohort study that will enroll \~22000 pregnant women aged 35 years and over from 9 large obstetrical center of University-Affiliated Hospitals. These hospitals locate at 7 supercities (Beijing, Shanghai, Guangdong, Shenyang, Wuhan, Chongqing and Chengdu) of China. Pregnant women who are planning to recieve prenatal healthcare and delivery in those hospitals are potential candidates for the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: At enrollment, 24-28 weeks, 32-34 weeks of gestation, delivery, and 42 days postpartum
Secondary outcomes:
measure: Maternal death
timeFrame: At 24-28 weeks, 32-34 weeks of gestation, delivery, and 42 days postpartum
measure: The rate of cesarean delivery
timeFrame: At delivery
measure: Gestational duration
timeFrame: At enrollment, delivery
measure: Birth weight
timeFrame: At delivery
measure: Birth length
timeFrame: At delivery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Obstetrics and Gynecology Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking University Third Hospital
city: Chengdu
country: China
facility: West China Second University Hospital
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital of Fudan University
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study officials:
affiliation: Peking University Third Hospital
name: Yangyu Zhao, PhD
role: STUDY_CHAIR
affiliation: Peking University
name: Jian-meng Liu, PhD
role: PRINCIPAL_INVESTIGATOR
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