Clinical trial NCT06414655: Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China
Official title: Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Chongqing Medical University
name: Shengjing Hospital
name: Peking University
name: Nankai University
name: Shanghai First Maternity and Infant Hospital
name: The First Affiliated Hospital of Anhui Medical University
name: International Peace Maternity and Child Health Hospital
name: The Second Hospital of Shandong University
name: Shandong Provincial Hospital
First posted: 2024-05-16
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

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

Primary outcomes:
measure: Rate of preterm delivery
timeFrame: From inclusion to delivery
measure: Rate of preeclampsia
timeFrame: From inclusion to delivery
measure: Rate of twin-to-twin transfusion syndrome (TTTS)
timeFrame: From inclusion to delivery
measure: Rate of selective fetal growth restriction (sFGR)
timeFrame: From inclusion to delivery
measure: Rate of fetal brain injury
timeFrame: From inclusion to delivery
measure: Rate of neonatal brain injury
timeFrame: From inclusion to delivery
measure: Rate of early childhood developmental delay of the offspring
timeFrame: Within 1 year after delivery
measure: Children's height
timeFrame: Within 1 year after delivery
measure: Children's weight
timeFrame: Within 1 year after delivery
Secondary outcomes:
measure: Rate of sleep disorders
timeFrame: From inclusion to delivery
measure: Rate of mental and phycological disorders
timeFrame: From inclusion to delivery
measure: Rate of single intrauterine fetal demise
timeFrame: From inclusion to delivery
measure: Rate of gestational hypertension
timeFrame: From inclusion to delivery
measure: Rate of gestational diabetes mellitus
timeFrame: From inclusion to delivery
measure: Number of maternal death
timeFrame: From inclusion to delivery
measure: Rate of stillbirth
timeFrame: From inclusion to delivery
measure: Birth weight
timeFrame: At delivery
measure: Birth length
timeFrame: At delivery
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Peking
country: China
facility: Peking University Third Hospital
state: Beijing
city: Peking
country: China
facility: Peking University
state: Beijing
city: Chongqing
country: China
facility: Chongqing Medical University
state: Chongqing
city: Guangzhou
country: China
facility: First Affiliated Hospital, Sun Yat-Sen University
state: Guangdong
city: Shenyang
country: China
facility: Shengjing Hospital
state: Liaoning
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
city: Jinan
country: China
facility: The Second Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: International Peace Maternity and Child Health Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital
state: Shanghai
city: Tianjin
country: China
facility: Nankai University
state: Tianjin
Study officials:
affiliation: Obstetrics and Gynecology Department of Peking University Third Hospital
name: Yuan Wei, PhD, MD
role: STUDY_CHAIR
References: