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University Hospital Advanced Age Pregnant Cohort (UNIHOPE)

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ClinicalTrials.gov Identifier: NCT03220750
Recruitment Status : Unknown
Verified July 2017 by Jianmeng Liu, Peking University.
Recruitment status was:  Recruiting
First Posted : July 18, 2017
Last Update Posted : July 18, 2017
Sponsor:
Collaborators:
Peking University Third Hospital
Peking University First Hospital
Obstetrics & Gynecology Hospital of Fudan University
Shengjing Hospital
The Third Affiliated Hospital of Guangzhou Medical University
West China Second University Hospital
First Affiliated Hospital of Chongqing Medical University
Beijing Obstetrics and Gynecology Hospital
Tongji Hospital
Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
Information provided by (Responsible Party):
Jianmeng Liu, Peking University

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.

Condition or disease
Advanced Maternal Age Pregnancy High Risk Pregnancy Perinatal Death Maternal Death Various Pregnancy Complications Stillbirth and Fetal Death Abortion, Spontaneous

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.

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Study Type : Observational
Estimated Enrollment : 22000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: University Hospital Advanced Age Pregnant Cohort
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Maternal death [ Time Frame: At 24-28 weeks, 32-34 weeks of gestation, delivery, and 42 days postpartum ]
    Deaths during pregnancy or less than 42 days after termination of pregnancy.

  2. The rate of cesarean delivery [ Time Frame: At delivery ]
    Cesarean rate is defined as the number of cesarean delivery divided by the number of live births.

  3. Gestational duration [ Time Frame: At enrollment, delivery ]
    The number of weeks from the first day of the woman's last recorded menstrual period to the day of delivery deaths occurring within 28 days.

  4. Birth weight [ Time Frame: At delivery ]
    Every newborn's weight will be measured twice, but if the difference between the two measurement results is more than 0.1 kg, it will be measured for the third time, Low birth weight was defined as birth weight <2500 g.

  5. Birth length [ Time Frame: At delivery ]
    Every newborn's length will be measured twice, but if the difference between the two measurement results is more than 0.1 kg, it will be measured for the third time.



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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220750


Contacts
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Contact: Jian-meng Liu, PhD 86-10-82801136 liujm@pku.edu.cn
Contact: Hong-tian Li, PhD 86-10-82801141 liht@bjmu.edu.cn

Locations
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China
Peking University First Hospital Active, not recruiting
Beijing, China, 100034
Beijing Obstetrics and Gynecology Hospital, Capital Medical University Active, not recruiting
Beijing, China, 100069
Peking University Third Hospital Recruiting
Beijing, China, 100191
Contact: Yangyu Zhao, MD    15611908315    yangaogi@163.com   
West China Second University Hospital Active, not recruiting
Chengdu, China, 610000
The First Affiliated Hospital of Chongqing Medical University Recruiting
Chongqing, China, 400010
Contact: Hongbo Qi, MD    13808376116    qihongbo728@163.com   
The Third Affiliated Hospital of Guangzhou Medical University Active, not recruiting
Guangzhou, China, 510000
Obstetrics and Gynecology Hospital of Fudan University Active, not recruiting
Shanghai, China, 200000
Shengjing Hospital of China Medical University Active, not recruiting
Shenyang, China, 110000
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Active, not recruiting
Wuhan, China, 430000
Sponsors and Collaborators
Peking University
Peking University Third Hospital
Peking University First Hospital
Obstetrics & Gynecology Hospital of Fudan University
Shengjing Hospital
The Third Affiliated Hospital of Guangzhou Medical University
West China Second University Hospital
First Affiliated Hospital of Chongqing Medical University
Beijing Obstetrics and Gynecology Hospital
Tongji Hospital
Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences
Investigators
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Study Chair: Yangyu Zhao, PhD Peking University Third Hospital
Principal Investigator: Jian-meng Liu, PhD Peking University
Publications:

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Responsible Party: Jianmeng Liu, Prof., Peking University
ClinicalTrials.gov Identifier: NCT03220750    
Other Study ID Numbers: 2016YFC1000401
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pregnancy Complications
Stillbirth
Fetal Death
Maternal Death
Abortion, Spontaneous
Perinatal Death
Death
Pathologic Processes
Parental Death