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Идёт набор NCT06414655

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

— Наблюдательное Twin Pregnancy, Antepartum Condition or Complication Twin to Twin Transfusion as Antepartum Condition Pre-Term Pre-Eclampsia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Twin Pregnancy, Antepartum Condition or Complication, Twin to Twin Transfusion as Antepartum Condition, Pre-Term, Pre-Eclampsia. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Обзор

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.

Подробное описание

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.

Первичные конечные точки

  • Rate of preterm delivery [Срок оценки: From inclusion to delivery]
  • Rate of preeclampsia [Срок оценки: From inclusion to delivery]
  • Rate of twin-to-twin transfusion syndrome (TTTS) [Срок оценки: From inclusion to delivery]
  • Rate of selective fetal growth restriction (sFGR) [Срок оценки: From inclusion to delivery]
  • Rate of fetal brain injury [Срок оценки: From inclusion to delivery]
  • Rate of neonatal brain injury [Срок оценки: From inclusion to delivery]
  • Rate of early childhood developmental delay of the offspring [Срок оценки: Within 1 year after delivery]
  • Children's height [Срок оценки: Within 1 year after delivery]
  • Children's weight [Срок оценки: Within 1 year after delivery]
Вторичные конечные точки (9)
  • Rate of sleep disorders [Срок оценки: From inclusion to delivery]
  • Rate of mental and phycological disorders [Срок оценки: From inclusion to delivery]
  • Rate of single intrauterine fetal demise [Срок оценки: From inclusion to delivery]
  • Rate of gestational hypertension [Срок оценки: From inclusion to delivery]
  • Rate of gestational diabetes mellitus [Срок оценки: From inclusion to delivery]
  • Number of maternal death [Срок оценки: From inclusion to delivery]
  • Rate of stillbirth [Срок оценки: From inclusion to delivery]
  • Birth weight [Срок оценки: At delivery]
  • Birth length [Срок оценки: At delivery]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 11 центров
  • The First Affiliated Hospital of Anhui Medical University — Хэфэй
  • Peking University Third Hospital — Пекин
  • Peking University — Пекин
  • Chongqing Medical University — Чунцин
  • First Affiliated Hospital, Sun Yat-Sen University — Гуанчжоу
  • Shengjing Hospital — Шэньян
  • Shandong Provincial Hospital — Цзинань
  • The Second Hospital of Shandong University — Цзинань
  • … и ещё 3 центра

Идентификаторы

NCT: NCT06414655 · ChiTwiMC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗