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Advanced Maternal Age PregnancyUNIHOPENCT03220750

University Hospital Advanced Age Pregnant Cohort

An observational study of Advanced Maternal Age Pregnancy and High Risk Pregnancy, run by Peking University at 9 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 35 to 60 years, women onlyHealthy volunteers can take part
How many people
22,000 participants
Where
9 sitesChina
Study dates
28 Mar 2017to 31 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 60 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • Female aged ≥ 35 years
  • Less than 14 gestational weeks
  • Planning to receive prenatal healthcare and delivery service at the study hospital

Who cannot join

  • Inability to provide informed consent
  • Women with mental disorders

Trial locations and contacts

9 sites in 1 country.

Jian-meng Liu, PhD contact

86-10-82801136

liujm@pku.edu.cn

Hong-tian Li, PhD contact

86-10-82801141

liht@bjmu.edu.cn

9 sites in 1 country

China9 sites, 2 recruiting

  • Peking University First Hospital

    Beijing, 100034

    Active, not recruiting

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing, 100069

    Active, not recruiting

  • Peking University Third Hospital

    Beijing, 100191

    Yangyu Zhao, MD, 15611908315, yangaogi@163.com

    Recruiting

  • West China Second University Hospital

    Chengdu, 610000

    Active, not recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400010

    Hongbo Qi, MD, 13808376116, qihongbo728@163.com

    Recruiting

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510000

    Active, not recruiting

  • Obstetrics and Gynecology Hospital of Fudan University

    Shanghai, 200000

    Active, not recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, 110000

    Active, not recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, 430000

    Active, not recruiting

Other trials in China

About this study

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.

Read the 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.

Medical subject headings
Perinatal Death, Maternal Death, Stillbirth, Fetal Death, Abortion, Spontaneous

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Gestational diabetes mellitus, hypertensive disease of pregnancy, uterine scar pregnancy, placenta previa, preterm delivery, postpartum hemorrhage, low birth weight, spontaneous abortion, stillbirth, perinatal death

    Measured: At enrollment, 24-28 weeks, 32-34 weeks of gestation, delivery, and 42 days postpartum

Secondary outcomes (5)

  1. Maternal death

    Deaths during pregnancy or less than 42 days after termination of pregnancy.

    Measured: At 24-28 weeks, 32-34 weeks of gestation, delivery, and 42 days postpartum

  2. The rate of cesarean delivery

    Cesarean rate is defined as the number of cesarean delivery divided by the number of live births.

    Measured: At delivery

  3. 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.

    Measured: At enrollment, delivery

  4. 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.

    Measured: At delivery

  5. 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.

    Measured: At delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2017
  2. Study start28 Mar 2017
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
22,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03220750
Sponsor's protocol ID
2016YFC1000401
Acronym
UNIHOPE
Status last verified
Jul 2017
First submitted
12 Jul 2017
Last updated
18 Jul 2017
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Laopaiboon M, Lumbiganon P, Intarut N, Mori R, Ganchimeg T, Vogel JP, Souza JP, Gulmezoglu 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.

    PubMed 24641535

  • 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.

    PubMed 23734279

  • 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.

    PubMed 23159159

  • 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.

    PubMed 23630102

  • 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.

    PubMed 28558024

  • 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. doi: 10.1097/01.AOG.0000158118.75532.51.

    PubMed 15863534

  • 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):541-548. doi: 10.1016/S1701-2163(16)34522-4.

    PubMed 20569534

  • 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.

    PubMed 28666302

  • 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.

    PubMed 28658853

  • 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. doi: 10.1093/humrep/15.11.2433.

    PubMed 11056148

  • Xu H, Liu Y, Bian X, Wang Z, Li Z, Zhen H, Xing S, Zhou J, Bai Z, Li J, Qiao C. Fetal growth in PCOS pregnancies: dynamic evidence of restriction and the modifying role of ART. Front Med (Lausanne). 2026 Jul 15;13:1857905. doi: 10.3389/fmed.2026.1857905. eCollection 2026.

    PubMed 42528920

  • Yuan P, Yin S, Guo X, Yang J, Li L, Wei Y, Zhao Y. Association of weekend delivery and perinatal outcomes following cesarean delivery: a retrospective analysis of a multicenter prospective cohort study in China. BMC Pregnancy Childbirth. 2026 Feb 16;26(1):314. doi: 10.1186/s12884-026-08759-1.

    PubMed 41692770

  • Yin S, Zhou Y, Zhao C, Yang J, Yuan P, Zhao Y, Qi H, Wei Y. Association of Paternal Age Alone and Combined with Maternal Age with Perinatal Outcomes: A Prospective Multicenter Cohort Study in China. J Epidemiol Glob Health. 2024 Mar;14(1):120-130. doi: 10.1007/s44197-023-00175-4. Epub 2024 Jan 8.

    PubMed 38190051

Questions about this trial

What is this clinical trial studying?

An observational study of Advanced Maternal Age Pregnancy and High Risk Pregnancy, run by Peking University at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jian-meng Liu, PhD (86-10-82801136, liujm@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03220750, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017.

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