Cohort of Twin Pregnancy and the Offspring

NCT05727085 | Recruiting

• 1 other identifier: TW20231535
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Twin Pregnancy

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (2)

• The level of twin Neurodevelopment assessed by Gesell Developmental Schedules

  Age at 3 years of the offspring

• The incidence of long term maternal complications

  Three years after delivery

Study Arms (1)

twins

Other: All pregnant women with a twin pregnancy and the offspring

Interventions

All pregnant women with a twin pregnancy and the offspring OTHER

No intervention

Also known as: No intervention

twins

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Woman with twin pregnancy and their male or female offspring.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Fetal chromosomal or congenital abnormalities.
• Stillbirth.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

RECRUITING

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 23, 2022
• First Posted: February 14, 2023
• Study Start: October 15, 2023
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2029
• Last Updated: March 14, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)