CTPO: Cohort of Twin Pregnancy and the Offspring

Sponsor
Fudan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05727085
Collaborator
(none)
1,000
1
71
14.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cohort of Twin Pregnancy and the Offspring
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2026
Anticipated Study Completion Date :
Jun 1, 2029

Arms and Interventions

Arm Intervention/Treatment
twins

Other: All pregnant women with a twin pregnancy and the offspring
No intervention
Other Names:
  • No intervention
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. RNA profiles in placentas of twin pregnancy measured by RNA-sequencing [Immediately after delivery]

      Levels of placental RNA expression.

    3. 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.

    4. Protein profiles in placentas of twin pregnancy measured by tandem mass tags quantification. [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. [Immediately after delivery]

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

    6. Metabolite profiles in placentas of twin pregnancy measured by metabolomics [Immediately after delivery]

      Metabolite profiles in placentas of twin pregnancy.

    7. Lipid profiles in placentas of twin pregnancy measured by lipidomic analysis [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 [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 [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 [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 [From confirmation of pregnancy to 42 days postpartum]

      Levels of specific lipids in maternal blood.

    Secondary Outcome Measures

    1. 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.

    2. The incidence of long term maternal complications [Three years after delivery]

      Including hypertension, diabetes mellitus and metabolic disease.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Maternal age >18 years old.

    2. Twin pregnancy.

    Exclusion Criteria:
    1. Fetal chromosomal or congenital abnormalities.

    2. Stillbirth.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Obstetrics and Gynecology Hospital of Fudan University Shanghai Shanghai China 200011

    Sponsors and Collaborators

    • Fudan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yu Xiong, Clinical Professor, Fudan University
    ClinicalTrials.gov Identifier:
    NCT05727085
    Other Study ID Numbers:
    • TW20231535
    First Posted:
    Feb 14, 2023
    Last Update Posted:
    Feb 14, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 14, 2023