Cohort of Twin Pregnancy and the Offspring (CTPO)

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.

Study Overview

• Status: Recruiting
• Conditions: Twin Pregnancy
• Intervention / Treatment: Other: All pregnant women with a twin pregnancy 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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Recruiting
      • Obstetrics and Gynecology Hospital of Fudan University
      • Contact: Yu Xiong, phd; Phone Number: +862163455050; Email: xiongyu1535@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Woman with twin pregnancy and their offspring within 3 years old.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
twins	Other: All pregnant women with a twin pregnancy and the offspring; No intervention; Other Names: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
RNA profiles in placentas of twin pregnancy measured by RNA-sequencing	Levels of placental RNA expression.	Immediately after delivery
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
Protein profiles in placentas of twin pregnancy measured by tandem mass tags quantification.	Levels of proteins in placentas of twin pregnancy.	Immediately after delivery
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
Metabolite profiles in placentas of twin pregnancy measured by metabolomics	Metabolite profiles in placentas of twin pregnancy.	Immediately after delivery
Lipid profiles in placentas of twin pregnancy measured by lipidomic analysis	Lipid profiles in placentas of twin pregnancy.	Immediately after delivery
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
The incidence of long term maternal complications	Including hypertension, diabetes mellitus and metabolic disease.	Three years after delivery

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: October 23, 2022
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 15, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: TW20231535

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No