NCT03220750

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 18, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

3.8 years

First QC Date

July 12, 2017

Last Update Submit

July 13, 2017

Conditions

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (5)

  • Maternal death

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

  • The rate of cesarean delivery

    At delivery

  • Gestational duration

    At enrollment, delivery

  • Birth weight

    At delivery

  • Birth length

    At delivery

Eligibility Criteria

Age35 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Inability to provide informed consent
  • Women with mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Peking University First Hospital

Beijing, 100034, China

ACTIVE NOT RECRUITING

Beijing Obstetrics and Gynecology Hospital, Capital Medical University

Beijing, 100069, China

ACTIVE NOT RECRUITING

Peking University Third Hospital

Beijing, 100191, China

RECRUITING

West China Second University Hospital

Chengdu, 610000, China

ACTIVE NOT RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400010, China

RECRUITING

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510000, China

ACTIVE NOT RECRUITING

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, 200000, China

ACTIVE NOT RECRUITING

Shengjing Hospital of China Medical University

Shenyang, 110000, China

ACTIVE NOT RECRUITING

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

Wuhan, 430000, China

ACTIVE NOT RECRUITING

Related Publications (11)

  • 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.

    PMID: 24641535BACKGROUND
  • 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.

    PMID: 23734279BACKGROUND
  • 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.

    PMID: 23159159BACKGROUND
  • 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.

    PMID: 23630102BACKGROUND
  • 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.

    PMID: 28558024BACKGROUND
  • 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.

    PMID: 15863534BACKGROUND
  • 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.

    PMID: 20569534BACKGROUND
  • 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.

    PMID: 28666302BACKGROUND
  • 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.

    PMID: 28658853BACKGROUND
  • 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.

    PMID: 11056148BACKGROUND
  • 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.

MeSH Terms

Conditions

Perinatal DeathMaternal DeathStillbirthFetal DeathAbortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and SymptomsParental Death

Study Officials

  • Yangyu Zhao, PhD

    Peking University Third Hospital

    STUDY CHAIR
  • Jian-meng Liu, PhD

    Peking University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian-meng Liu, PhD

CONTACT

Hong-tian Li, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

July 12, 2017

First Posted

July 18, 2017

Study Start

March 28, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

July 18, 2017

Record last verified: 2017-07

Locations