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NCT Number: NCT05727085

Cohort of Twin Pregnancy and the Offspring

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.

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Key information

Conditions

Twin Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location status: Recruiting

Location contact

Yu Xiong, phd

CONTACT

[email protected]

+862163455050

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Fetal chromosomal or congenital abnormalities.
  • Stillbirth.

Treatment and study plan

All pregnant women with a twin pregnancy and the offspring

Other

No intervention

Other names: No intervention

Primary outcomes

  1. The incidence of maternal and fetal complications

    Time frame: 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.

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

    Time frame: Immediately after delivery

    Levels of placental RNA expression.

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

    Time frame: Immediately after delivery

    Global DNA methylation levels in placentas of twin pregnancy.

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

    Time frame: Immediately after delivery

    Levels of proteins in placentas of twin pregnancy.

  5. Post-translation modification of proteins in placentas of twin pregnancy measured by Integrative use of phosphoproteomics, ubiquitylproteomics and acetylproteomics.

    Time frame: Immediately after delivery

    Post-translational levels of proteins in placentas of twin pregnancy.

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

    Time frame: Immediately after delivery

    Metabolite profiles in placentas of twin pregnancy.

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

    Time frame: Immediately after delivery

    Lipid profiles in placentas of twin pregnancy.

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

    Time frame: From confirmation of pregnancy to 42 days postpartum

    Levels of specific proteins in maternal blood.

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

    Time frame: From confirmation of pregnancy to 42 days postpartum

    Levels of specific RNAs in maternal blood.

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

    Time frame: From confirmation of pregnancy to 42 days postpartum

    Levels of specific metabolites in maternal blood.

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

    Time frame: From confirmation of pregnancy to 42 days postpartum

    Levels of specific lipids in maternal blood.

Secondary outcomes

  1. The level of twin Neurodevelopment assessed by Gesell Developmental Schedules

    Time frame: Age at 3 years of the offspring

    The parameters in Gesell Developmental Schedules including adaptive, gross motor, fine motor, language, and social function.

  2. The incidence of long term maternal complications

    Time frame: Three years after delivery

    Including hypertension, diabetes mellitus and metabolic disease.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Acronym: CTPO

Important dates

Study start
2023
Primary completion
2026
Study completion
2029
First posted
Feb 14, 2023
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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