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

Twin; Pregnancy, Affecting Fetus or Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05674214
• Other study ID #: ThirdGuangzhouMU_QL Cui
• Status: Completed
• Start date: September 10, 2020
• Est. completion date: November 25, 2022

Study information

• Verified date: January 2023
• Source: The Third Affiliated Hospital of Guangzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13440
• Est. completion date: November 25, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Twin; Pregnancy, Affecting Fetus or Newborn

Locations

Country	Name	City	State
China	Bijun Shi	Guangzhou	Guangdong

Sponsors (21)

Lead Sponsor

Collaborator

The Third Affiliated Hospital of Guangzhou Medical University

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

Country where clinical trial is conducted

China, 

References & Publications (7)

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 co — View 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: 10.10 — View 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 N — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	birth outcome	gestational age	1 day
Primary	neonatal complications	the morbidity of pulmonary hemorrhage, BPD, NEC, PDA, ROP, PVL, IVH, anemia, infection, etc	1 month
Secondary	discharge outcome	total hospitalization cost	3 months
Secondary	discharge outcome	length of stay	3 months