Cohort of Twin Pregnancy and the Offspring

Обзор

Twin pregnancy increases the risk of maternal and fetal complications, which include gestational hypertension, premature labor, twin-to-twin transfusion syndrome, intrauterine growth restriction, anemia, amniotic fluid abnormalities. Comprehensively understanding the molecular mechanisms of the disease and identification of markers contribute to development of novel therapeutic approaches. In addition, the twin pregnancy, especially the monochorionic, is an essential model of "experiments of nature". This model can be applied to distinguish the epigenetic differences of twins in utero and after birth in the same genomic context. The aim of the study is to constitute a prospective cohort of twin pregnancies and the offspring.

Подробное описание

Data are collected regarding the pregnancy data of the mother, and mental, physical and sociodemographic information of the offspring. The periods span from diagnosis of twins to 3 years old of the offspring. Biological samples would be collected including maternal blood, placental tissues, cord blood, urine, and stool from the pregnant women or the offspring at the specific time.

The total estimated duration of the study is 6 years, of which the first 2.5 years will correspond to the recruitment period of the participants.

Вмешательства

• Другое All pregnant women with a twin pregnancy and the offspring
  No intervention

Первичные конечные точки

• The incidence of maternal and fetal complications [Срок оценки: From confirmation of pregnancy to 42 days postpartum]
• RNA profiles in placentas of twin pregnancy measured by RNA-sequencing [Срок оценки: Immediately after delivery]
• Global DNA methylation in placentas of twin pregnancy measured by whole-genome bisulfite sequencing [Срок оценки: Immediately after delivery]
• Protein profiles in placentas of twin pregnancy measured by tandem mass tags quantification. [Срок оценки: Immediately after delivery]
• Post-translation modification of proteins in placentas of twin pregnancy measured by Integrative use of phosphoproteomics, ubiquitylproteomics and acetylproteomics. [Срок оценки: Immediately after delivery]
• Metabolite profiles in placentas of twin pregnancy measured by metabolomics [Срок оценки: Immediately after delivery]
• Lipid profiles in placentas of twin pregnancy measured by lipidomic analysis [Срок оценки: Immediately after delivery]
• Predictive protein markers of maternal and fetal complications in maternal blood measured by tandem mass tags quantification [Срок оценки: From confirmation of pregnancy to 42 days postpartum]
• Predictive RNA markers of maternal and fetal complications in maternal blood measured by RNA-sequencing [Срок оценки: From confirmation of pregnancy to 42 days postpartum]
• Predictive metabolite markers of maternal and fetal complications in maternal blood measured by metabolomics [Срок оценки: From confirmation of pregnancy to 42 days postpartum]

Вторичные конечные точки (2)

• The level of twin Neurodevelopment assessed by Gesell Developmental Schedules [Срок оценки: Age at 3 years of the offspring]
• The incidence of long term maternal complications [Срок оценки: Three years after delivery]

Критерии участия

Критерии включения

• Maternal age >18 years old.
• Twin pregnancy.

Критерии исключения

• Fetal chromosomal or congenital abnormalities.
• Stillbirth.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Obstetrics and Gynecology Hospital of Fudan University — Шанхай

Идентификаторы

NCT: NCT05727085 · TW20231535

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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