Clinical trial NCT05674214: Birth Weight-discordance in Twins Pregnancy: a Multicenter Retrospective Study
Official title: Occurrence of Liveborn Twins With Birth Weight-discordance and Its Relationship to the Adverse Outcomes: a Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Twin; Pregnancy, Affecting Fetus or Newborn
Keywords: twins
birth weigh-discordant
occurrence
birth outcomes
multi-center study
Lead sponsor: The Third Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: The Affiliated Hospital of Inner Mongolia Medical University
name: The Third Hospital Of BaoGang Group
name: Lanzhou University Second Hospital
name: Yan'an University Affiliated Hospital
name: Xiamen University Women and Children's Hospital
name: Xinxiang Central Hospital
name: Central Hospital of Xiaogan
name: Guizhou Medical University Affiliated Hospital
name: Sichuan Jinxin Women and Children's Hospital
name: The First Affiliated Hospital of Shaoyang University
name: First Affiliated Hospital of Jinan University
name: First Affiliated Hospital of Shantou University Medical College
name: Second Affiliated Hospital of Shantou University Medical College
name: The Second People's Hospital of GuangDong Province
name: Dongguan People's Hospital
name: Dongguan Binhai Bay Central Hospital
name: Zhongshan People's Hospital, Guangdong, China
name: Huizhou Municipal Central Hospital
name: Yuebei People's Hospital
First posted: 2023-01-06
Enrollment: 13440
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: live twin births

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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: birth outcome
timeFrame: 1 day
measure: neonatal complications
timeFrame: 1 month
Secondary outcomes:
measure: discharge outcome
timeFrame: 3 months
measure: discharge outcome
timeFrame: 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Bijun Shi
state: Guangdong
Study officials:
References:
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citation: 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.
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citation: 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.
citation: 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.