University Hospital Advanced Age Pregnant Cohort

Study Overview
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Brief Summary
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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
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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.

Official Title
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University Hospital Advanced Age Pregnant Cohort

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

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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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 | 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 | 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 | Cesarean rate is defined as the number of cesarean delivery divided by the number of live births. | 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. | 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. | 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. | At delivery |