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

NCT06414655 | Recruiting

• 1 other identifier: ChiTwiMC
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (9)

• Rate of sleep disorders

  From inclusion to delivery

• Rate of mental and phycological disorders

  From inclusion to delivery

• Rate of single intrauterine fetal demise

  From inclusion to delivery

• Rate of gestational hypertension

  From inclusion to delivery

• Rate of gestational diabetes mellitus

  From inclusion to delivery

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Chongqing Medical University: collaborator
• Shengjing Hospital: collaborator
• Peking University: collaborator
• Nankai University: collaborator
• Shanghai First Maternity and Infant Hospital: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• International Peace Maternity and Child Health Hospital: collaborator
• The Second Hospital of Shandong University: collaborator
• Shandong Provincial Hospital: collaborator

Study Sites (11)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230001, China

RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Peking University

Beijing, Beijing Municipality, 10091, China

RECRUITING

Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Shengjing Hospital

Shenyang, Liaoning, 110000, China

RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

RECRUITING

The Second Hospital of Shandong University

Jinan, Shandong, 250033, China

RECRUITING

International Peace Maternity and Child Health Hospital

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, 201204, China

RECRUITING

Nankai University

Tianjin, Tianjin Municipality, 300071, China

RECRUITING

Biospecimen

Retention: NONE RETAINED

Collecting peripheral venous blood from husband, hair during the first trimester, peripheral venous blood and cervicovaginal secretions during the first trimester, second trimester, late pregnancy before labor, placental tissue, amionic fluid and umbilical cord blood during delivery, hair, meconium of newborns, and buccal mucosa from infants.

MeSH Terms

Conditions

Premature Birth; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced

Study Officials

• Yuan Wei, PhD, MD

  Obstetrics and Gynecology Department of Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

Yuan Wei, PhD, MD

CONTACT

01082267852; weiyuanbysy@163.com

Tianchen Wu, PhD

CONTACT

wtc17@pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: May 16, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)