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Cohort of Twin Pregnancy and the Offspring

Cohort of Twin Pregnancy and the Offspring

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05727085
Acronym
CTPO
Enrollment
1000
Registered
2023-02-14
Start date
2023-10-15
Completion date
2029-06-15
Last updated
2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Twin Pregnancy

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.

Interventions

OTHERAll pregnant women with a twin pregnancy and the offspring

No intervention

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Maternal age \>18 years old. 2. Twin pregnancy.

Exclusion criteria

1. Fetal chromosomal or congenital abnormalities. 2. Stillbirth.

Design outcomes

Primary

MeasureTime frameDescription
Predictive lipid markers of maternal and fetal complications in maternal blood measured by lipidomic analysisFrom confirmation of pregnancy to 42 days postpartumLevels of specific lipids in maternal blood.
Predictive RNA markers of maternal and fetal complications in maternal blood measured by RNA-sequencingFrom confirmation of pregnancy to 42 days postpartumLevels of specific RNAs in maternal blood.
Predictive metabolite markers of maternal and fetal complications in maternal blood measured by metabolomicsFrom confirmation of pregnancy to 42 days postpartumLevels of specific metabolites in maternal blood.
The incidence of maternal and fetal complicationsFrom confirmation of pregnancy to 42 days postpartumThe 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-sequencingImmediately after deliveryLevels of placental RNA expression.
Global DNA methylation in placentas of twin pregnancy measured by whole-genome bisulfite sequencingImmediately after deliveryGlobal DNA methylation levels in placentas of twin pregnancy.
Protein profiles in placentas of twin pregnancy measured by tandem mass tags quantification.Immediately after deliveryLevels of proteins in placentas of twin pregnancy.
Post-translation modification of proteins in placentas of twin pregnancy measured by Integrative use of phosphoproteomics, ubiquitylproteomics and acetylproteomics.Immediately after deliveryPost-translational levels of proteins in placentas of twin pregnancy.
Metabolite profiles in placentas of twin pregnancy measured by metabolomicsImmediately after deliveryMetabolite profiles in placentas of twin pregnancy.
Lipid profiles in placentas of twin pregnancy measured by lipidomic analysisImmediately after deliveryLipid profiles in placentas of twin pregnancy.
Predictive protein markers of maternal and fetal complications in maternal blood measured by tandem mass tags quantificationFrom confirmation of pregnancy to 42 days postpartumLevels of specific proteins in maternal blood.

Secondary

MeasureTime frameDescription
The incidence of long term maternal complicationsThree years after deliveryIncluding hypertension, diabetes mellitus and metabolic disease.
The level of twin Neurodevelopment assessed by Gesell Developmental SchedulesAge at 3 years of the offspringThe parameters in Gesell Developmental Schedules including adaptive, gross motor, fine motor, language, and social function.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026