Cohort of Twin Pregnancy and the Offspring

Twin Pregnancy Clinical Trial

— CTPO  

Official title:

Cohort of Twin Pregnancy and the Offspring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05727085
• Other study ID #: TW20231535
• Status: Recruiting
• Start date: July 2023
• Est. completion date: June 2029

Study information

• Verified date: July 2023
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 2029
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Maternal age >18 years old.

2. Twin pregnancy.

Exclusion Criteria:

1. Fetal chromosomal or congenital abnormalities.

2. Stillbirth.

Related Conditions & MeSH terms

• Twin Pregnancy

Intervention

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

Locations

Country	Name	City	State
China	Obstetrics and Gynecology Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of maternal and fetal complications	The incidence of preeclampsia, gestational diabetes mellitus, premature delivery, postpartum hemorrhage, twin to twin transfusion syndrome, selective intrauterine growth restriction.	From confirmation of pregnancy to 42 days postpartum
Primary	RNA profiles in placentas of twin pregnancy measured by RNA-sequencing	Levels of placental RNA expression.	Immediately after delivery
Primary	Global DNA methylation in placentas of twin pregnancy measured by whole-genome bisulfite sequencing	Global DNA methylation levels in placentas of twin pregnancy.	Immediately after delivery
Primary	Protein profiles in placentas of twin pregnancy measured by tandem mass tags quantification.	Levels of proteins in placentas of twin pregnancy.	Immediately after delivery
Primary	Post-translation modification of proteins in placentas of twin pregnancy measured by Integrative use of phosphoproteomics, ubiquitylproteomics and acetylproteomics.	Post-translational levels of proteins in placentas of twin pregnancy.	Immediately after delivery
Primary	Metabolite profiles in placentas of twin pregnancy measured by metabolomics	Metabolite profiles in placentas of twin pregnancy.	Immediately after delivery
Primary	Lipid profiles in placentas of twin pregnancy measured by lipidomic analysis	Lipid profiles in placentas of twin pregnancy.	Immediately after delivery
Primary	Predictive protein markers of maternal and fetal complications in maternal blood measured by tandem mass tags quantification	Levels of specific proteins in maternal blood.	From confirmation of pregnancy to 42 days postpartum
Primary	Predictive RNA markers of maternal and fetal complications in maternal blood measured by RNA-sequencing	Levels of specific RNAs in maternal blood.	From confirmation of pregnancy to 42 days postpartum
Primary	Predictive metabolite markers of maternal and fetal complications in maternal blood measured by metabolomics	Levels of specific metabolites in maternal blood.	From confirmation of pregnancy to 42 days postpartum
Primary	Predictive lipid markers of maternal and fetal complications in maternal blood measured by lipidomic analysis	Levels of specific lipids in maternal blood.	From confirmation of pregnancy to 42 days postpartum
Secondary	The level of twin Neurodevelopment assessed by Gesell Developmental Schedules	The parameters in Gesell Developmental Schedules including adaptive, gross motor, fine motor, language, and social function.	Age at 3 years of the offspring
Secondary	The incidence of long term maternal complications	Including hypertension, diabetes mellitus and metabolic disease.	Three years after delivery