Cohort of Twin Pregnancy and the Offspring

Recruiting

• Conditions: Twin Pregnancy
• Interventions: Other: All pregnant women with a twin pregnancy and the offspring

• Registration Number: NCT05727085
• Lead Sponsor: Fudan University

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.

Study Timeline

• Study First Submitted: 2022-10-23
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-14
• Status Verified: 2023-07
• Study Start: 2023-07
• Last Update Submitted: 2023-07-15
• Last Update Posted: 2023-07-18
• Primary Completion: 2026-06
• Study Completion: 2029-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
twins	All pregnant women with a twin pregnancy and the offspring	-

Primary Outcome Measures

Name	Time	Method
Protein profiles in placentas of twin pregnancy measured by tandem mass tags quantification.	Immediately after delivery	Levels of proteins in placentas of twin pregnancy.
Global DNA methylation in placentas of twin pregnancy measured by whole-genome bisulfite sequencing	Immediately after delivery	Global DNA methylation levels in placentas of twin pregnancy.
Metabolite profiles in placentas of twin pregnancy measured by metabolomics	Immediately after delivery	Metabolite profiles in placentas of twin pregnancy.
Lipid profiles in placentas of twin pregnancy measured by lipidomic analysis	Immediately after delivery	Lipid profiles in placentas of twin pregnancy.
Predictive lipid markers of maternal and fetal complications in maternal blood measured by lipidomic analysis	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.	Immediately after delivery	Post-translational levels of proteins in placentas of twin pregnancy.
The incidence of maternal and fetal complications	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	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	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	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	From confirmation of pregnancy to 42 days postpartum	Levels of specific metabolites in maternal blood.

Secondary Outcome Measures

Name	Time	Method
The incidence of long term maternal complications	Three years after delivery	Including hypertension, diabetes mellitus and metabolic disease.
The level of twin Neurodevelopment assessed by Gesell Developmental Schedules	Age at 3 years of the offspring	The parameters in Gesell Developmental Schedules including adaptive, gross motor, fine motor, language, and social function.

Trial Locations

Locations (1)

Obstetrics and Gynecology Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China