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NCT Number: NCT05674214

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

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.

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Key information

Conditions

Twin; Pregnancy, Affecting Fetus or Newborn

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Bijun Shi

Guangzhou, Guangdong, 510150, China

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

live twin births

  • delivered from 2018 to 2020

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. birth outcome

    Time frame: 1 day

    gestational age

  2. neonatal complications

    Time frame: 1 month

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

Secondary outcomes

  1. discharge outcome

    Time frame: 3 months

    total hospitalization cost

  2. discharge outcome

    Time frame: 3 months

    length of stay

Sponsors and collaborators

Lead sponsor

The Third Affiliated Hospital of Guangzhou Medical University

Other

Collaborators

  • Central Hospital of Xiaogan
  • Dongguan Binhai Bay Central Hospital
  • Dongguan People's Hospital
  • First Affiliated Hospital of Jinan University
  • First Affiliated Hospital of Shantou University Medical College
  • Huizhou Municipal Central Hospital
  • Lanzhou University Second Hospital
  • Peking University Third Hospital
  • Second Affiliated Hospital of Shantou University Medical College
  • Sichuan Jinxin Women and Children's Hospital
  • The Affiliated Hospital Of Guizhou Medical University
  • The Affiliated Hospital of Inner Mongolia Medical University
  • The First Affiliated Hospital of Shaoyang University
  • The Second People's Hospital of GuangDong Province
  • The Third Hospital Of BaoGang Group
  • Xiamen University Women and Children's Hospital
  • Xinxiang Central Hospital
  • Yan'an University Affiliated Hospital
  • Yuebei People's Hospital
  • Zhongshan People's Hospital, Guangdong, China

Registry information

Official study title

Occurrence of Liveborn Twins With Birth Weight-discordance and Its Relationship to the Adverse Outcomes: a Multicenter Retrospective Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 6, 2023
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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