Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Twin Pregnancy, Antepartum Condition or Complication, Twin to Twin Transfusion as Antepartum Condition, Pre-Term, Pre-Eclampsia. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Primary outcome measures
- Rate of preterm delivery [Time frame: From inclusion to delivery]
- Rate of preeclampsia [Time frame: From inclusion to delivery]
- Rate of twin-to-twin transfusion syndrome (TTTS) [Time frame: From inclusion to delivery]
- Rate of selective fetal growth restriction (sFGR) [Time frame: From inclusion to delivery]
- Rate of fetal brain injury [Time frame: From inclusion to delivery]
- Rate of neonatal brain injury [Time frame: From inclusion to delivery]
- Rate of early childhood developmental delay of the offspring [Time frame: Within 1 year after delivery]
- Children's height [Time frame: Within 1 year after delivery]
- Children's weight [Time frame: Within 1 year after delivery]
Secondary outcome measures (9)
- Rate of sleep disorders [Time frame: From inclusion to delivery]
- Rate of mental and phycological disorders [Time frame: From inclusion to delivery]
- Rate of single intrauterine fetal demise [Time frame: From inclusion to delivery]
- Rate of gestational hypertension [Time frame: From inclusion to delivery]
- Rate of gestational diabetes mellitus [Time frame: From inclusion to delivery]
- Number of maternal death [Time frame: From inclusion to delivery]
- Rate of stillbirth [Time frame: From inclusion to delivery]
- Birth weight [Time frame: At delivery]
- Birth length [Time frame: At delivery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
China · 11 centers
- The First Affiliated Hospital of Anhui Medical University — Hefei
- Peking University Third Hospital — Beijing
- Peking University — Beijing
- Chongqing Medical University — Chongqing
- First Affiliated Hospital, Sun Yat-Sen University — Guangzhou
- Shengjing Hospital — Shenyang
- Shandong Provincial Hospital — Jinan
- The Second Hospital of Shandong University — Jinan
- … and 3 more centers
Identifiers
NCT: NCT06414655 · ChiTwiMC