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the Prognosis of Fetoscopy Treatment of Twin Transfusion Syndrome

Sponsor
Shengjing Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04952415
Collaborator
(none)
100
Enrollment
1
Location
60
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Fetal medicine in China is still a new, young discipline, and the development is very rapid. After nearly 10 years of development, the clinical diagnosis and treatment guidelines of some complicated twin diseases has been established. Among them, twin-to-twin-transfusion syndrome (TTTS) is serious disease in twin pregnancy, and the factors affecting prognosis after fetoscopic laser surgery are part of the study. Through this study, the investigators expect to achieve better prediction indicators of the prognosis of TTTS.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    A better guideline for twin-to-twin-transfusion syndrome are anticipated to be established in China. Fetoscopic laser surgery is applied to treat TTTS. After surgery, better prediction indicators of the prognosis of TTTS are needed.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    the Prognosis of Fetoscopy Treatment of Twin Transfusion Syndrome in Shengjing Hospital
    Anticipated Study Start Date :
    Jul 1, 2021
    Anticipated Primary Completion Date :
    Jul 1, 2022
    Anticipated Study Completion Date :
    Jul 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Weight in kilogram of neonate [At birth of neonate]

      Including twin pregnancy of TTTS after fetoscopic laser surgery measured by nurses

    Secondary Outcome Measures

    1. Neurodevelopment at early childhood [At age of 1 year old]

      Including adaptive, gross motor, fine motor, language, and social function; assessed using Gesell Developmental Schedules.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    TTTS after fetoscopic laser surgery.

    Exclusion Criteria:

    Pregnant women who refuse to take part in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shengjing Hospital Shenyang Liaoning China 110004

    Sponsors and Collaborators

    • Shengjing Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Caixia Liu, Director of the second obstetrical department, Shengjing Hospital
    ClinicalTrials.gov Identifier:
    NCT04952415
    Other Study ID Numbers:
    • PFTTTTS
    First Posted:
    Jul 7, 2021
    Last Update Posted:
    Jul 7, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Caixia Liu, Director of the second obstetrical department, Shengjing Hospital
    TTTS
    Additional relevant MeSH terms:
    Fetofetal Transfusion

    Study Results

    No Results Posted as of Jul 7, 2021