NCT05674214

Brief Summary

The rate of twin pregnancies in China has increased by 50 percent over the past decade and now stands at about 3 percent. This is significantly higher than the European and American countries. There are significant differences in birth weight of some newborns, that is, birth weight-discordance in twin pregnancies (BWDT). BWDT was significantly associated with fetal death, preterm birth, neonatal death, and neonatal complications. Existing studies mainly focus on the perinatal outcomes of mothers and infants with BWDT, or are reported from small samples in developed countries. The investigators are aware of the need to further explore the occurrence of birth weight inconsistency and adverse neonatal outcomes in China with a large sample. Through retrospective study design, the investigators will collect clinical data of live twin births at multiple study sites, investigate the incidence of BWDT, and analyze its adverse outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13,440

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 10, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
Last Updated

June 7, 2023

Status Verified

January 1, 2023

Enrollment Period

2.1 years

First QC Date

November 30, 2022

Last Update Submit

June 6, 2023

Conditions

Twin; Pregnancy, Affecting Fetus or Newborn

Keywords

twinsbirth weigh-discordantoccurrencebirth outcomesmulti-center study

Outcome Measures

Primary Outcomes (2)

  • birth outcome

    gestational age

    1 day

  • neonatal complications

    the morbidity of pulmonary hemorrhage, BPD, NEC, PDA, ROP, PVL, IVH, anemia, infection, etc

    1 month

Secondary Outcomes (2)

  • discharge outcome

    3 months

  • discharge outcome

    3 months

Study Arms (2)

birth weight-discordant group

the birth weight difference within twins is greater than 20%

the birth weight-concordant group

the birth weight difference within twins is less than or equal to 20%

Eligibility Criteria

Age1 Day - 28 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

live twin births

You may qualify if:

  • live twin births
  • \. delivered from 2018 to 2020

You may not qualify if:

  • congenital and hereditary diseases
  • inherited metabolic diseases
  • complex congenital heart disease
  • digestive tract malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bijun Shi

Guangzhou, Guangdong, 510150, China

Location

Related Publications (7)

  • Hiersch L, Barrett J, Aviram A, Mei-Dan E, Yoon EW, Zaltz A, Kingdom J, Melamed N. Patterns of discordant growth and adverse neonatal outcomes in twins. Am J Obstet Gynecol. 2021 Aug;225(2):187.e1-187.e14. doi: 10.1016/j.ajog.2021.01.018. Epub 2021 Jan 25.

    PMID: 33508311RESULT

  • D'Antonio F, Thilaganathan B, Laoreti A, Khalil A; Southwest Thames Obstetric Research Collaborative (STORK). Birth-weight discordance and neonatal morbidity in twin pregnancy: analysis of STORK multiple pregnancy cohort. Ultrasound Obstet Gynecol. 2018 Nov;52(5):586-592. doi: 10.1002/uog.18916. Epub 2018 Oct 8.

    PMID: 29028139RESULT

  • Jahanfar S, Lim K, Oviedo-Joekes E. Stillbirth Associated With Birth Weight Discordance in Twin Gestations. J Obstet Gynaecol Can. 2019 Jan;41(1):52-58. doi: 10.1016/j.jogc.2018.02.017. Epub 2018 Oct 10.

    PMID: 30316716RESULT

  • Miller J, Chauhan SP, Abuhamad AZ. Discordant twins: diagnosis, evaluation and management. Am J Obstet Gynecol. 2012 Jan;206(1):10-20. doi: 10.1016/j.ajog.2011.06.075. Epub 2011 Jun 25.

    PMID: 21864822RESULT

  • Diaz-Garcia C, Bernard JP, Ville Y, Salomon LJ. Validity of sonographic prediction of fetal weight and weight discordance in twin pregnancies. Prenat Diagn. 2010 Apr;30(4):361-7. doi: 10.1002/pd.2469.

    PMID: 20187000RESULT

  • D'Antonio F, Odibo AO, Prefumo F, Khalil A, Buca D, Flacco ME, Liberati M, Manzoli L, Acharya G. Weight discordance and perinatal mortality in twin pregnancy: systematic review and meta-analysis. Ultrasound Obstet Gynecol. 2018 Jul;52(1):11-23. doi: 10.1002/uog.18966.

    PMID: 29155475RESULT

  • D'Antonio F, Khalil A, Dias T, Thilaganathan B; Southwest Thames Obstetric Research Collaborative (STORK). Weight discordance and perinatal mortality in twins: analysis of the Southwest Thames Obstetric Research Collaborative (STORK) multiple pregnancy cohort. Ultrasound Obstet Gynecol. 2013 Jun;41(6):643-8. doi: 10.1002/uog.12412. Epub 2013 Apr 22.

    PMID: 23355123RESULT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2022

First Posted

January 6, 2023

Study Start

September 10, 2020

Primary Completion

October 1, 2022

Study Completion

November 25, 2022

Last Updated

June 7, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)