University Hospital Advanced Age Pregnant Cohort

High Risk Pregnancy Clinical Trial

— UNIHOPE  

Official title:

University Hospital Advanced Age Pregnant Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03220750
• Other study ID #: 2016YFC1000401
• Status: Recruiting
• Phase: N/A
• First received: July 12, 2017
• Last updated: July 13, 2017
• Start date: March 28, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2017
• Source: Peking University
• Contact: Jian-meng Liu, PhD
• Phone: 86-10-82801136
• Email: liujm[@]pku.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22000
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Beijing Obstetrics and Gynecology Hospital, Capital Medical University	Beijing
China	Peking University First Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	West China Second University Hospital	Chengdu
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing
China	The Third Affiliated Hospital of Guangzhou Medical University	Guangzhou
China	Obstetrics and Gynecology Hospital of Fudan University	Shanghai
China	Shengjing Hospital of China Medical University	Shenyang
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan

Sponsors (11)

Lead Sponsor

Collaborator

Peking University

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

Country where clinical trial is conducted

China, 

References & Publications (10)

Carolan M. Maternal age =45 years and maternal and perinatal outcomes: a review of the evidence. Midwifery. 2013 May;29(5):479-89. doi: 10.1016/j.midw.2012.04.001. Epub 2012 Nov 16. Review. — View Citation

Cleary-Goldman J, Malone FD, Vidaver J, Ball RH, Nyberg DA, Comstock CH, Saade GR, Eddleman KA, Klugman S, Dugoff L, Timor-Tritsch IE, Craigo SD, Carr SR, Wolfe HM, Bianchi DW, D'Alton M; FASTER Consortium. Impact of maternal age on obstetric outcome. Obstet Gynecol. 2005 May;105(5 Pt 1):983-90. — View Citation

Jolly M, Sebire N, Harris J, Robinson S, Regan L. The risks associated with pregnancy in women aged 35 years or older. Hum Reprod. 2000 Nov;15(11):2433-7. — View Citation

Khalil A, Syngelaki A, Maiz N, Zinevich Y, Nicolaides KH. Maternal age and adverse pregnancy outcome: a cohort study. Ultrasound Obstet Gynecol. 2013 Dec;42(6):634-43. doi: 10.1002/uog.12494. — View Citation

Laopaiboon M, Lumbiganon P, Intarut N, Mori R, Ganchimeg T, Vogel JP, Souza JP, Gülmezoglu AM; WHO Multicountry Survey on Maternal Newborn Health Research Network. Advanced maternal age and pregnancy outcomes: a multicountry assessment. BJOG. 2014 Mar;121 Suppl 1:49-56. doi: 10.1111/1471-0528.12659. — View Citation

Lisonkova S, Janssen PA, Sheps SB, Lee SK, Dahlgren L. The effect of maternal age on adverse birth outcomes: does parity matter? J Obstet Gynaecol Can. 2010 Jun;32(6):541-8. — View Citation

Lisonkova S, Potts J, Muraca GM, Razaz N, Sabr Y, Chan WS, Kramer MS. Maternal age and severe maternal morbidity: A population-based retrospective cohort study. PLoS Med. 2017 May 30;14(5):e1002307. doi: 10.1371/journal.pmed.1002307. eCollection 2017 May. — View Citation

Ngowa JD, Ngassam AN, Dohbit JS, Nzedjom C, Kasia JM. Pregnancy outcome at advanced maternal age in a group of African women in two teaching Hospitals in Yaounde, Cameroon. Pan Afr Med J. 2013 Apr 7;14:134. doi: 10.11604/pamj.2013.14.134.2315. Print 2013. — View Citation

Niessen K, Werner-Bierwisch T, Metzing S, Sayn-Wittgenstein FZ. [Motherhood at the Age of 35 and Over: The Risk of Advanced Maternal Age as Perceived by Women - a Literature Study]. Z Geburtshilfe Neonatol. 2017 Jun;221(3):111-121. doi: 10.1055/s-0043-104864. Epub 2017 Jun 30. German. — View Citation

Taghizadeh Z, Cheraghi MA, Kazemnejad A, Pooralajal J, Aghababaei S. Difference in Perception of Pregnancy Risk in Two Maternal Age Groups. J Clin Diagn Res. 2017 May;11(5):QC09-QC12. doi: 10.7860/JCDR/2017/23661.9915. Epub 2017 May 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	The rate of cesarean delivery	Cesarean rate is defined as the number of cesarean delivery divided by the number of live births.	At delivery
Secondary	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
Secondary	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
Secondary	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