Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China (ChiTwiMC)

Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China (ChiTwiMC) is supported by National Key Research and Development Program of China - Reproductive Health and Women's and Children's Health Protection Project. This project is funded by the Ministry of Science and Technology of China under grant number 2023YFC2705900. The ChiTwiMC cohort is led by Professor Wei Yuan from the Department of Gynecology and Obstetrics at Peking University Third Hospital.

Study Overview

• Status: Recruiting
• Conditions: Pre-Eclampsia; High Risk Pregnancy; Twin Pregnancy, Antepartum Condition or Complication; Pre-Term; Twin Dichorionic Diamniotic Placenta; Twin to Twin Transfusion as Antepartum Condition; Twin Placenta; Twin Monochorionic Diamniotic Placenta

Detailed Description

The ChiTwiMC Cohort focusing on the serious complications of twin pregnancy, establish a multicenter large prospective mother-child cohort of twin pregnancy covering pregnancy→neonatal period→early childhood, and a multi-variety, multi-stage biobank for the study of adverse outcomes of twin pregnancy. The ChiTwiMC Cohort is planning to recruit 2000 pregnant women aged 18-45 years from 9 large obstetrical center of major University-affiliated Hospitals across China, between December 2023 and May 2026. All women will be enrolled prior to 14 wks of gestation, pregnancy was followed up at 22-28 wks, 30-38 wks of gestation, delivery, postpartum 42 days, 6 months, 12 months. Data including demographics, medical history, reproductive history, clinical diagnosis, treatment information, and pregnancy and birth outcomes will be collected via electronic data capture system. Track the outcome of severe maternal-fetal complications and early neonatal outcomes of twins, and collect biological samples, including peripheral venous blood, hair and cervicovaginal secretions from pregnant women, placenta tissue, amniotic fluid and unbilical cord blood at delivery, meconium and hair from newborns, buccal mucosa from infants and peripheral venous blood from the husband.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Yuan Wei, PhD, MD; Phone Number: 01082267852; Email: weiyuanbysy@163.com
• Study Contact Backup: Name: Tianchen Wu, PhD; Email: wtc17@pku.edu.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Recruiting
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Zongzhi Yin; Email: dr_yinzongzhi@qq.com
  • Beijing
    • Peking, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Tianchen Wu, PhD; Email: wtc17@pku.edu.cn
      • Contact: Yuan Wei, PhD, MD; Email: weiyuanbysy@163.com
    • Peking, Beijing, China, 10091
      • Recruiting
      • Peking University
      • Contact: Xiaoli Wang; Email: xlwang@bjmu.edu.cn
  • Chongqing
    • Chongqing, Chongqing, China, 400010
      • Recruiting
      • Chongqing Medical University
      • Contact: Yubin Ding; Email: dingyb@cqmu.edu.cn
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • First Affiliated Hospital, Sun Yat-Sen University
      • Contact: Yanmin Luo; Email: luoyanm@mail.sysu.edu.cn
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • Recruiting
      • Shengjing Hospital
      • Contact: Jun Wei; Email: Weij@sj-hospital.org
  • Shandong
    • Jinan, Shandong, China, 250021
      • Recruiting
      • Shandong Provincial Hospital
      • Contact: Jinlai Meng; Email: adokemeng@163.com
    • Jinan, Shandong, China, 250033
      • Recruiting
      • The Second Hospital of Shandong University
      • Contact: Fanzhen Hong; Email: hongfz@sdu.edu.cn
  • Shanghai
    • Shanghai, Shanghai, China, 201204
      • Recruiting
      • Shanghai First Maternity and Infant Hospital
      • Contact: Gang Zou; Email: zougangshcn@sina.com
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • International Peace Maternity and Child Health Hospital
      • Contact: Yanlin Wang; Email: wyanlin@163.com
  • Tianjin
    • Tianjin, Tianjin, China, 300071
      • Recruiting
      • Nankai University
      • Contact: Ling Shuai; Email: lshuai@nankai.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

The ChiTwiMC is a prospective cohort that will enroll 2000 pregnant women aged 18-45 years and over from 9 large obstetrical centers of University-Affiliated Hospitals (Peking University Third Hospital; First Affiliated Hospital, Sun Yat-Sen University; Chongqing Medical University; Shengjing Hospital; Shanghai First Maternity and Infant Hospital; The First Affiliated Hospital of Anhui Medical University; International Peace Maternity and Child Health Hospital; The Second Hospital of Shandong University; Shandong Provincial Hospital). These hospitals located at 7 supercities (Beijing, Shanghai, Guangzhou, Shenyang, Jinan, Chongqing, and Hefei) of China. Pregnant women who are planning to receive prenatal healthcare and delivery in those hospitals are potential candidates for the study.

Description

Inclusion Criteria:

• Twin pregnancies
• Female aged between 18-45 years
• Gestational age is less than 14 weeks
• Planning to receive prenatal healthcare and delivery service at the study hospital
• Signing informed concent and willing to participate

Exclusion Criteria:

• Women with mental disorders or serious maternal illness that is not eligible to participate
• Inability to provide informed consent
• Pregnant women not registered in our hospital

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of preterm delivery	Preterm delivery is defined as delivery between 28 and 37 gestational weeks.	From inclusion to delivery
Rate of preeclampsia	Preeclampsia is defined as the condition occurring in pregnant women after 20 weeks of gestation, characterized by systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, accompanied by any of the following: a urinary protein quantification ≥0.3 g/24 h, or a urine protein/creatinine ratio ≥0.3, or random urine protein ≥ (+) (as a method of examination when protein quantification is not feasible). In the absence of proteinuria, the condition may still be diagnosed if there is involvement of any organ or system, including but not limited to critical organs such as the heart, lungs, liver, kidneys, or abnormalities in the hematological, digestive, or neurological systems, as well as complications affecting the placenta-fetus.	From inclusion to delivery
Rate of twin-to-twin transfusion syndrome (TTTS)	TTTS is diagnosed in monochorionic diamniotic twin pregnancies when there is a discordance in amniotic fluid volumes, with one fetus exhibiting polyhydramnios and the other oligohydramnios. Specifically, before 20 weeks of gestation, the condition is diagnosed if one fetus (the recipient) has a deepest vertical pocket (DVP) of amniotic fluid ≥8cm, while the other fetus (the donor) has a DVP ≤2cm; after 20 weeks of gestation, the diagnosis is made if one fetus (the recipient) has a DVP ≥10cm, while the other fetus (the donor) has a DVP ≤2cm.	From inclusion to delivery
Rate of selective fetal growth restriction (sFGR)	sFGR is diagnosed in monochorionic diamniotic twin pregnancies when one fetus has an estimated fetal weight below the 10th percentile for its gestational age, and there is a discrepancy of ≥25% in the estimated fetal weights between the two fetuses.	From inclusion to delivery
Rate of fetal brain injury	Fetal brain injury is an abnormality in the structural and functional integrity of the cerebrum, cerebellum, or brainstem during the gestational period, caused by various factors such as hypoxic-ischemic events, infections, hemorrhage, congenital malformations, and genetic metabolic disorders.	From inclusion to delivery
Rate of neonatal brain injury	Brain injury refers to damage to the central nervous system resulting from various risk factors during pregnancy, childbirth, and the neonatal period. Clinically, it manifests as central motor disorders, cognitive impairments, language disorders, visual and auditory impairments, as well as difficulties in social interaction and psychological and behavioral disorders. It needs pregnant history or birth history, (such as one of twin intrauterine fetal death, Intrauterine distress), manifestation, and ultrasound, CT, MRI, electroencephalogram to make a definite diagnosis.	From inclusion to delivery
Rate of early childhood developmental delay of the offspring	Early childhood developmental delay of the offspring refers to a significant lag or delay in achieving age-appropriate developmental milestones across one or more domains, including cognitive, language, motor, social-emotional, and adaptive skills, during the early years of life (typically from birth to 5 years of age) in comparison to established norms or peers. The assessment of early childhood developmental delay is conducted using standardized scales such as Ages Stages Questionnaires (Third Edition), Gesell Developmental Schedules, and Bayley Scales of Infant and Toddler Development. The actual measurement process will be depending on the routine pediatric settings and resources available at each participating institution.	Within 1 year after delivery
Children's height	Each child is measured twice. If the difference is less than 0.1 cm, the average of the two measurements is taken. If the difference is greater than 0.1 cm, the measurement is repeated.	Within 1 year after delivery
Children's weight	Each newborn is measured twice. If the difference is less than 0.01 kg, the average of the two measurements is taken. If the difference is greater than 0.01 kg, the measurement is repeated.	Within 1 year after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of sleep disorders	Women's physiological and psychological changes during pregnancy will affect sleep, and the occurrence of bad sleep during pregnancy is more common. It is generally assessed by a sleep questionnaire.	From inclusion to delivery
Rate of mental and phycological disorders	Maternal mental health is as important as physical health, and good maternal mental health helps to promote the physical and mental health of the baby, as well as their own physical condition and natural childbirth. The condition of pregnant women is generally assessed by psychiatric departments.	From inclusion to delivery
Rate of single intrauterine fetal demise	The death of one fetus for twin pregnancy，the occurrence in the second and third trimesters of pregnancy has substantial adverse effects on surviving infants.	From inclusion to delivery
Rate of gestational hypertension	Take two consecutive measurements on the same arm, the systolic blood pressure more than 140 mmHg and (or) the diastolic blood pressure more than 90 mmHg. High blood pressure may lead to severe complications such as preclampsia and clampsia.	From inclusion to delivery
Rate of gestational diabetes mellitus	Diagnosed with gestational diabetes through an oral glucose tolerance test (OGTT). The blood glucose threshold of fasting, 1 h and 2 h after taking oral glucose was 5.1, 10.0, 8.5 mmolL, respectively, and the blood glucose level reached or exceeded the above criteria at any time point was diagnosed as GDM. GDM is clearly associated with adverse pregnancy outcomes such as fetal macrosomia, cesarean section delivery, preterm birth, and preeclampsia	From inclusion to delivery
Number of maternal death	Deaths during pregnancy or less than 42 days after termination of pregnancy.	From inclusion to delivery
Rate of stillbirth	After 28 gestational weeks, the fetus dies before or during delivery	From inclusion to delivery
Birth weight	Each newborn is measured twice. If the difference is less than 0.01 kg, the average of the two measurements is taken. If the difference is greater than 0.01 kg, the measurement is repeated.	At delivery
Birth length	Each newborn is measured twice. If the difference is less than 0.1 cm, the average of the two measurements is taken. If the difference is greater than 0.1 cm, the measurement is repeated.	At delivery

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Peking University; The First Affiliated Hospital of Anhui Medical University; First Affiliated Hospital, Sun Yat-Sen University; Shengjing Hospital; Shandong Provincial Hospital; Chongqing Medical University; The Second Hospital of Shandong University; Shanghai First Maternity and Infant Hospital; International Peace Maternity and Child Health Hospital; Nankai University
• Investigators: Study Chair: Yuan Wei, PhD, MD, Obstetrics and Gynecology Department of Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: March 17, 2024
• First Submitted That Met QC Criteria: May 9, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hematologic Diseases; Infant, Newborn, Diseases; Anemia; Pregnancy Complications; Hypertension, Pregnancy-Induced; Anemia, Neonatal; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Disease; Eclampsia; Pre-Eclampsia; Fetofetal Transfusion
• Other Study ID Numbers: ChiTwiMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We have decided that the program will be confidential and not open to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No