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Cohort of Twin Pregnancy and the Offspring (CTPO)

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ClinicalTrials.gov Identifier: NCT05727085
Recruitment Status : Recruiting
First Posted : February 14, 2023
Last Update Posted : July 18, 2023
Sponsor:
Information provided by (Responsible Party):
Yu Xiong, Fudan University

Tracking Information
First Submitted Date October 23, 2022
First Posted Date February 14, 2023
Last Update Posted Date July 18, 2023
Estimated Study Start Date July 2023
Estimated Primary Completion Date June 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 13, 2023)
  • 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.
  • RNA profiles in placentas of twin pregnancy measured by RNA-sequencing [ Time Frame: Immediately after delivery ]
    Levels of placental RNA expression.
  • 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.
  • 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.
  • 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.
  • Metabolite profiles in placentas of twin pregnancy measured by metabolomics [ Time Frame: Immediately after delivery ]
    Metabolite profiles in placentas of twin pregnancy.
  • Lipid profiles in placentas of twin pregnancy measured by lipidomic analysis [ Time Frame: Immediately after delivery ]
    Lipid profiles in placentas of twin pregnancy.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 13, 2023)
  • 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.
  • The incidence of long term maternal complications [ Time Frame: Three years after delivery ]
    Including hypertension, diabetes mellitus and metabolic disease.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cohort of Twin Pregnancy and the Offspring
Official Title Cohort of Twin Pregnancy and the Offspring
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Woman with twin pregnancy and their offspring within 3 years old.
Condition Twin Pregnancy
Intervention Other: All pregnant women with a twin pregnancy and the offspring
No intervention
Other Name: No intervention
Study Groups/Cohorts twins
Intervention: Other: All pregnant women with a twin pregnancy and the offspring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 13, 2023)		 1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2029
Estimated Primary Completion Date June 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Fetal chromosomal or congenital abnormalities.
  2. Stillbirth.
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Woman with twin pregnancy and their male or female offspring.
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT05727085
Other Study ID Numbers TW20231535
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Current Responsible Party Yu Xiong, Fudan University
Original Responsible Party Same as current
Current Study Sponsor Fudan University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Fudan University
Verification Date July 2023