Skip to main content
Clinical Trials/NCT05727085
NCT05727085
Recruiting
Not Applicable

Cohort of Twin Pregnancy and the Offspring

Fudan University1 site in 1 country1,000 target enrollmentOctober 15, 2023
ConditionsTwin Pregnancy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Twin Pregnancy
Sponsor
Fudan University
Enrollment
1000
Locations
1
Primary Endpoint
Protein profiles in placentas of twin pregnancy measured by tandem mass tags quantification.
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2023
End Date
June 15, 2029
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yu Xiong

Clinical Professor

Fudan University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Fetal chromosomal or congenital abnormalities.
  • Stillbirth.

Outcomes

Primary Outcomes

Protein profiles in placentas of twin pregnancy measured by tandem mass tags quantification.

Time Frame: Immediately after delivery

Levels of proteins in placentas of twin pregnancy.

Lipid profiles in placentas of twin pregnancy measured by lipidomic analysis

Time Frame: Immediately after delivery

Lipid profiles in placentas of twin pregnancy.

Global DNA methylation in placentas of twin pregnancy measured by whole-genome bisulfite sequencing

Time Frame: Immediately after delivery

Global DNA methylation levels in placentas of twin pregnancy.

Metabolite profiles in placentas of twin pregnancy measured by metabolomics

Time Frame: Immediately after delivery

Metabolite profiles in placentas of twin pregnancy.

Predictive lipid markers of maternal and fetal complications in maternal blood measured by lipidomic analysis

Time Frame: From confirmation of pregnancy to 42 days postpartum

Levels of specific lipids in maternal blood.

Post-translation modification of proteins in placentas of twin pregnancy measured by Integrative use of phosphoproteomics, ubiquitylproteomics and acetylproteomics.

Time Frame: Immediately after delivery

Post-translational levels of proteins in placentas of twin pregnancy.

The incidence of maternal and fetal complications

Time Frame: From confirmation of pregnancy to 42 days postpartum

The incidence of preeclampsia, gestational diabetes mellitus, premature delivery, postpartum hemorrhage, twin to twin transfusion syndrome, selective intrauterine growth restriction.

RNA profiles in placentas of twin pregnancy measured by RNA-sequencing

Time Frame: Immediately after delivery

Levels of placental RNA expression.

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

Levels of specific proteins in maternal blood.

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

Levels of specific RNAs in maternal blood.

Predictive metabolite markers of maternal and fetal complications in maternal blood measured by metabolomics

Time Frame: From confirmation of pregnancy to 42 days postpartum

Levels of specific metabolites in maternal blood.

Secondary Outcomes

  • The incidence of long term maternal complications(Three years after delivery)
  • The level of twin Neurodevelopment assessed by Gesell Developmental Schedules(Age at 3 years of the offspring)

Study Sites (1)

Loading locations...

Similar Trials