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RecruitingNCT05727085CTPOUpdated Mar 14, 2025

Cohort of Twin Pregnancy and the Offspring

An observational study in Twin Pregnancy, sponsored by Fudan University. Recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-14.

Sponsored by Fudan University · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Oct 2023; still recruiting 2 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Twin Pregnancy
03

In context

Lead sponsor

Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Fetal chromosomal or congenital abnormalities.
  2. Stillbirth.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • twins

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

Interventions

  • OtherAll pregnant women with a twin pregnancy and the offspring

    No intervention

    Also known as: No intervention

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From confirmation of pregnancy to 42 days postpartum

  2. RNA profiles in placentas of twin pregnancy measured by RNA-sequencing

    Levels of placental RNA expression.

    Time frame: Immediately after delivery

  3. Global DNA methylation in placentas of twin pregnancy measured by whole-genome bisulfite sequencing

    Global DNA methylation levels in placentas of twin pregnancy.

    Time frame: Immediately after delivery

  4. Protein profiles in placentas of twin pregnancy measured by tandem mass tags quantification.

    Levels of proteins in placentas of twin pregnancy.

    Time frame: Immediately after delivery

  5. 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.

    Time frame: Immediately after delivery

  6. Metabolite profiles in placentas of twin pregnancy measured by metabolomics

    Metabolite profiles in placentas of twin pregnancy.

    Time frame: Immediately after delivery

  7. Lipid profiles in placentas of twin pregnancy measured by lipidomic analysis

    Lipid profiles in placentas of twin pregnancy.

    Time frame: Immediately after delivery

  8. Predictive protein markers of maternal and fetal complications in maternal blood measured by tandem mass tags quantification

    Levels of specific proteins in maternal blood.

    Time frame: From confirmation of pregnancy to 42 days postpartum

  9. Predictive RNA markers of maternal and fetal complications in maternal blood measured by RNA-sequencing

    Levels of specific RNAs in maternal blood.

    Time frame: From confirmation of pregnancy to 42 days postpartum

  10. Predictive metabolite markers of maternal and fetal complications in maternal blood measured by metabolomics

    Levels of specific metabolites in maternal blood.

    Time frame: From confirmation of pregnancy to 42 days postpartum

  11. Predictive lipid markers of maternal and fetal complications in maternal blood measured by lipidomic analysis

    Levels of specific lipids in maternal blood.

    Time frame: From confirmation of pregnancy to 42 days postpartum

Secondary outcomes

  1. 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.

    Time frame: Age at 3 years of the offspring

  2. The incidence of long term maternal complications

    Including hypertension, diabetes mellitus and metabolic disease.

    Time frame: Three years after delivery

07

Study locations

1 of 1 sites recruiting
  • Obstetrics and Gynecology Hospital of Fudan University
    Shanghai, Shanghai 200011, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05727085
Lead sponsor
Fudan University
Responsible party
Yu Xiong (Clinical Professor, Fudan University) — Principal investigator
First posted
Feb 14, 2023
Start date
Oct 15, 2023
Primary completion
Jun 15, 2026 (estimated)
Completion
Jun 15, 2029 (estimated)
Last update
Mar 14, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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