An observational study in Advanced Maternal Age Pregnancy, High Risk Pregnancy and Perinatal Death, sponsored by Peking University. Status unknown at 9 sites in China. Open to female participants aged 35 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-18.
Sponsored by Peking University · Observational
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.
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.
120 studies on the registry are indexed under Perinatal Death; 25 are open to participants now.
This study's planned enrollment of 22,000 is above the median of 525 across 33 observational studies indexed under Perinatal Death.
Browse Perinatal Death studies →Peking University is the lead sponsor of 419 studies on the registry; 123 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Gestational diabetes mellitus, hypertensive disease of pregnancy, uterine scar pregnancy, placenta previa, preterm delivery, postpartum hemorrhage, low birth weight, spontaneous abortion, stillbirth, perinatal death
Time frame: At enrollment, 24-28 weeks, 32-34 weeks of gestation, delivery, and 42 days postpartum
Maternal death
Deaths during pregnancy or less than 42 days after termination of pregnancy.
Time frame: At 24-28 weeks, 32-34 weeks of gestation, delivery, and 42 days postpartum
The rate of cesarean delivery
Cesarean rate is defined as the number of cesarean delivery divided by the number of live births.
Time frame: At delivery
Gestational duration
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.
Time frame: At enrollment, delivery
Birth weight
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.
Time frame: At delivery
Birth length
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.
Time frame: At delivery
Plan to share: Undecided
This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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