Birth Weight-discordance in Twins Pregnancy: a Multicenter Retrospective Study

NCT ID: NCT05674214

Last Updated: 2023-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

13440 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-10

Study Completion Date

2022-11-25

Brief Summary

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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.

Detailed Description

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The investigators adopted a multicenter retrospective case-control study design and enrolled live twin births delivered from 2018 to 2020 in 22 hospitals in 12 provinces in China. Children with congenital and hereditary diseases, such as inherited metabolic diseases, complex congenital heart disease, and digestive tract malformations, were excluded from the study. The investigators collected the following information: (1) General information: maternal age, year of delivery, number of delivery, mode of conception, mode of delivery, chorionic nature, education level, newborn sex; (2) Maternal risk factors associated with intrauterine development: induced abortion ≥2 times, placental disease, uterine tumor, gestational diabetes mellitus, gestational hypertension disease, intrahepatic cholestasis, connective tissue disease, hypothyroidism, and chorionic amnitis; (3) Infant birth outcome: gestational age, birth weight, birth length, birth head circumference, very low birth weight infants, ultra-low birth weight infants, the Apgar score, whether transferred to neonatology department. (4) Information of hospitalization during the neonatal period: Pulmonary surfactant use, duration of oxygen therapy, neonatal complications (i.e., pulmonary hemorrhage, BPD, NEC, PDA, ROP, PVL, IVH, anemia, infection, etc.), feeding status (i.e., duration of milk opening, duration of full feeding, feeding style and feeding materials at full feeding, Time to recovery of birth weight), and discharge outcome (i.e., total hospitalization cost, length of stay, gestational age corrected for discharge, discharge status, discharge physique).

Conditions

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Twin; Pregnancy, Affecting Fetus or Newborn

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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birth weight-discordant group

the birth weight difference within twins is greater than 20%

No interventions assigned to this group

the birth weight-concordant group

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

live twin births

1\. delivered from 2018 to 2020

Exclusion Criteria

1. congenital and hereditary diseases
2. inherited metabolic diseases
3. complex congenital heart disease
4. digestive tract malformations
Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role collaborator

The Affiliated Hospital of Inner Mongolia Medical University

OTHER

Sponsor Role collaborator

The Third Hospital Of BaoGang Group

UNKNOWN

Sponsor Role collaborator

Lanzhou University Second Hospital

OTHER

Sponsor Role collaborator

Yan'an University Affiliated Hospital

OTHER

Sponsor Role collaborator

Xiamen University Women and Children's Hospital

UNKNOWN

Sponsor Role collaborator

Xinxiang Central Hospital

OTHER

Sponsor Role collaborator

Central Hospital of Xiaogan

OTHER

Sponsor Role collaborator

Guizhou Medical University Affiliated Hospital

UNKNOWN

Sponsor Role collaborator

Sichuan Jinxin Women and Children's Hospital

UNKNOWN

Sponsor Role collaborator

The First Affiliated Hospital of Shaoyang University

UNKNOWN

Sponsor Role collaborator

First Affiliated Hospital of Jinan University

OTHER

Sponsor Role collaborator

First Affiliated Hospital of Shantou University Medical College

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Shantou University Medical College

OTHER

Sponsor Role collaborator

The Second People's Hospital of GuangDong Province

OTHER

Sponsor Role collaborator

Dongguan People's Hospital

OTHER_GOV

Sponsor Role collaborator

Dongguan Binhai Bay Central Hospital

UNKNOWN

Sponsor Role collaborator

Zhongshan People's Hospital, Guangdong, China

OTHER

Sponsor Role collaborator

Huizhou Municipal Central Hospital

OTHER

Sponsor Role collaborator

Yuebei People's Hospital

OTHER

Sponsor Role collaborator

The Third Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Bijun Shi

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 33508311 (View on PubMed)

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.

Reference Type RESULT
PMID: 29028139 (View on PubMed)

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.

Reference Type RESULT
PMID: 30316716 (View on PubMed)

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.

Reference Type RESULT
PMID: 21864822 (View on PubMed)

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.

Reference Type RESULT
PMID: 20187000 (View on PubMed)

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.

Reference Type RESULT
PMID: 29155475 (View on PubMed)

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.

Reference Type RESULT
PMID: 23355123 (View on PubMed)

Other Identifiers

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ThirdGuangzhouMU_QL Cui

Identifier Type: -

Identifier Source: org_study_id

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