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Prenatal Screening, Diagnosis and Intrauterine Intervention of Fetal Abnormal Chromosome and Structure in Twins Pregnancy

Primary Purpose

Chromosome Abnormality, Twin Pregnancy With Antenatal Problem

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fetal Selective Reduction Technology
Potassium Chloride
Sponsored by
Shanghai First Maternity and Infant Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chromosome Abnormality

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ultrasound diagnosis as twin pregnancy
  • at 11-14 gestational weeks

Exclusion Criteria:

  • Multiple pregnancies (three or more)
  • Maternal history of chromosome aneuploidy abnormality or tumor

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    No Intervention

    Arm Label

    Fetal Selective Reduction Technology

    control group

    Arm Description

    Potassium chloride fetal heart injection in the dichorial twins with abnormal chromosome and structure

    normal dichorial twins without any intervention

    Outcomes

    Primary Outcome Measures

    Success rate for the operation

    Secondary Outcome Measures

    long-term complications after surgery

    Full Information

    First Posted
    November 29, 2016
    Last Updated
    December 2, 2016
    Sponsor
    Shanghai First Maternity and Infant Hospital
    Collaborators
    Children's Hospital of Fudan University, International Peace Maternity and Child Health Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02982356
    Brief Title
    Prenatal Screening, Diagnosis and Intrauterine Intervention of Fetal Abnormal Chromosome and Structure in Twins Pregnancy
    Official Title
    Prenatal Screening, Diagnosis and Intrauterine Intervention of Fetal Abnormal Chromosome and Structure in Twins Pregnancy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai First Maternity and Infant Hospital
    Collaborators
    Children's Hospital of Fudan University, International Peace Maternity and Child Health Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The risk of abnormal chromosome and structure is much higher in twins than in singletons, and traditional early pregnancy screening strategy for single pregnancy is not suitable for twins. Based on our management experience of fetal medicine at twin pregnancy, and multi-center cooperation, the study will carry out the following clinical studies: to explore a suitable, early, noninvasive and accurate prenatal screening strategy for twin pregnancy. fetal chromosomal abnormalities

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chromosome Abnormality, Twin Pregnancy With Antenatal Problem

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    1300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fetal Selective Reduction Technology
    Arm Type
    Other
    Arm Description
    Potassium chloride fetal heart injection in the dichorial twins with abnormal chromosome and structure
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    normal dichorial twins without any intervention
    Intervention Type
    Procedure
    Intervention Name(s)
    Fetal Selective Reduction Technology
    Intervention Description
    Fetal Selective Reduction Technology will be conducted according to different gestational weeks: before 16weeks, 16~24 weeks, 24~27+6 weeks,>28weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Potassium Chloride
    Primary Outcome Measure Information:
    Title
    Success rate for the operation
    Time Frame
    1 week
    Secondary Outcome Measure Information:
    Title
    long-term complications after surgery
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ultrasound diagnosis as twin pregnancy at 11-14 gestational weeks Exclusion Criteria: Multiple pregnancies (three or more) Maternal history of chromosome aneuploidy abnormality or tumor

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    The Individual Participant Data sharing plan will be discussed with the other collaborators

    Learn more about this trial

    Prenatal Screening, Diagnosis and Intrauterine Intervention of Fetal Abnormal Chromosome and Structure in Twins Pregnancy

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