University Hospital Advanced Age Pregnant Cohort (UNIHOPE)

July 13, 2017 updated by: Jianmeng Liu, Peking University
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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

22000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Contact:
      • Beijing, China, 100034
        • Active, not recruiting
        • Peking University First Hospital
      • Beijing, China, 100069
        • Active, not recruiting
        • Beijing Obstetrics and Gynecology Hospital, Capital Medical University
      • Chengdu, China, 610000
        • Active, not recruiting
        • West China Second University Hospital
      • Chongqing, China, 400010
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
      • Guangzhou, China, 510000
        • Active, not recruiting
        • The Third Affiliated Hospital of Guangzhou Medical University
      • Shanghai, China, 200000
        • Active, not recruiting
        • Obstetrics and Gynecology Hospital of Fudan University
      • Shenyang, China, 110000
        • Active, not recruiting
        • Shengjing Hospital of China Medical University
      • Wuhan, China, 430000
        • Active, not recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At enrollment, 24-28 weeks, 32-34 weeks of gestation, delivery, and 42 days postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 24-28 weeks, 32-34 weeks of gestation, delivery, and 42 days postpartum
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.
At delivery
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.
At enrollment, delivery
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.
At delivery
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.
At delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Collaborators

Peking University First Hospital
Peking University Third Hospital
The Third Affiliated Hospital of Guangzhou Medical University
Tongji Hospital
Shengjing Hospital
Obstetrics & Gynecology Hospital of Fudan University
First Affiliated Hospital of Chongqing Medical University
West China Second University Hospital
Beijing Obstetrics and Gynecology Hospital
Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences

Investigators

  • Study Chair: Yangyu Zhao, PhD, Peking University Third Hospital
  • Principal Investigator: Jian-meng Liu, PhD, Peking University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2017

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

July 12, 2017

First Submitted That Met QC Criteria

July 13, 2017

First Posted (Actual)

July 18, 2017

Study Record Updates

Last Update Posted (Actual)

July 18, 2017

Last Update Submitted That Met QC Criteria

July 13, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016YFC1000401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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