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Recruiting NCT05727085

Cohort of Twin Pregnancy and the Offspring

— Observational Twin Pregnancy

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
The protocol lists: All pregnant women with a twin pregnancy and the offspring.
Who it may be relevant to
Registry conditions: Twin Pregnancy. Basic parameters: from 18 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 →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

  • The incidence of maternal and fetal complications [Time frame: From confirmation of pregnancy to 42 days postpartum]
  • RNA profiles in placentas of twin pregnancy measured by RNA-sequencing [Time frame: Immediately after delivery]
  • Global DNA methylation in placentas of twin pregnancy measured by whole-genome bisulfite sequencing [Time frame: Immediately after delivery]
  • Protein profiles in placentas of twin pregnancy measured by tandem mass tags quantification. [Time frame: Immediately after delivery]
  • Post-translation modification of proteins in placentas of twin pregnancy measured by Integrative use of phosphoproteomics, ubiquitylproteomics and acetylproteomics. [Time frame: Immediately after delivery]
  • Metabolite profiles in placentas of twin pregnancy measured by metabolomics [Time frame: Immediately after delivery]
  • Lipid profiles in placentas of twin pregnancy measured by lipidomic analysis [Time frame: Immediately after delivery]
  • Predictive protein markers of maternal and fetal complications in maternal blood measured by tandem mass tags quantification [Time frame: From confirmation of pregnancy to 42 days postpartum]
  • Predictive RNA markers of maternal and fetal complications in maternal blood measured by RNA-sequencing [Time frame: From confirmation of pregnancy to 42 days postpartum]
  • Predictive metabolite markers of maternal and fetal complications in maternal blood measured by metabolomics [Time frame: From confirmation of pregnancy to 42 days postpartum]
Secondary outcome measures (2)
  • The level of twin Neurodevelopment assessed by Gesell Developmental Schedules [Time frame: Age at 3 years of the offspring]
  • The incidence of long term maternal complications [Time frame: Three years after delivery]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Fetal chromosomal or congenital abnormalities.
  • Stillbirth.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Obstetrics and Gynecology Hospital of Fudan University — Shanghai

Identifiers

NCT: NCT05727085 · TW20231535

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗