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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

Study Description
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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
Twin Pregnancy 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
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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cohort of Twin Pregnancy and the Offspring
Estimated Study Start Date : July 2023
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : June 2029

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
twins Other: All pregnant women with a twin pregnancy and the offspring
No intervention
Other Name: No intervention


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Woman with twin pregnancy and their male or female offspring.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Woman with twin pregnancy and their offspring within 3 years old.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Fetal chromosomal or congenital abnormalities.
  2. Stillbirth.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05727085


Locations
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China, Shanghai
Obstetrics and Gynecology Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 200011
Contact: Yu Xiong, phd    +862163455050    xiongyu1535@163.com   
Sponsors and Collaborators
Fudan University
More Information
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Responsible Party: Yu Xiong, Clinical Professor, Fudan University
ClinicalTrials.gov Identifier: NCT05727085    
Other Study ID Numbers: TW20231535
First Posted: February 14, 2023    Key Record Dates
Last Update Posted: July 18, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No