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

NCT ID: NCT06414655

Last Updated: 2024-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

Chongqing Medical University

OTHER

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role collaborator

Peking University

OTHER

Sponsor Role collaborator

Nankai University

OTHER

Sponsor Role collaborator

Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

International Peace Maternity and Child Health Hospital

OTHER

Sponsor Role collaborator

The Second Hospital of Shandong University

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuan Wei, PhD, MD

Role: STUDY_CHAIR

Obstetrics and Gynecology Department of Peking University Third Hospital

Locations

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The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status RECRUITING

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Shengjing Hospital

Shenyang, Liaoning, China

Site Status RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

Site Status RECRUITING

The Second Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

International Peace Maternity and Child Health Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Nankai University

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuan Wei, PhD, MD

Role: CONTACT

01082267852

Tianchen Wu, PhD

Role: CONTACT

Facility Contacts

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Zongzhi Yin

Role: primary

Yuan Wei, PhD, MD

Role: primary

Tianchen Wu, PhD

Role: backup

Xiaoli Wang

Role: primary

Yubin Ding

Role: primary

Yanmin Luo

Role: primary

Jun Wei

Role: primary

Jinlai Meng

Role: primary

Fanzhen Hong

Role: primary

Yanlin Wang

Role: primary

Gang Zou

Role: primary

Ling Shuai

Role: primary

Other Identifiers

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ChiTwiMC

Identifier Type: -

Identifier Source: org_study_id

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