Diagnosis and Intervention of Complicated Twin Diseases
1 other identifier
interventional
100
1 country
1
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 , but they are still needed to be improved. Through this study, the investigators expect to achieve better prediction indicators and early intrauterine precise diagnosis of complicated twin diseases. Also, better procedures of implementing effective intrauterine intervention and assessing the safety and effectiveness of intrauterine intervention are anticipated to be established.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2018
CompletedFirst Posted
Study publicly available on registry
August 29, 2018
CompletedStudy Start
First participant enrolled
August 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedSeptember 5, 2018
September 1, 2018
1.9 years
August 27, 2018
September 2, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Gene expression of fetuses
DNA methylation, histone acetylation etc. assessed by analyses of fetal blood and amniotic fluid.
At 20 week of gestational age
Change of volume of amniotic fluid in Milliliter
Measured by doctors of sonography
At every two week from the sixteenth week of gestational age to delivery of babies
Change of umbilical artery blood flow
Measured by doctors of sonography
At every two week from the sixteenth week of gestational age to delivery of babies
Secondary Outcomes (1)
Neurodevelopment at early childhood
At age of 1 year old
Study Arms (1)
TOCTD
EXPERIMENTALPregnancy women with complicated twin diseases, who are able to withstand risks of intrauterine treatments and informed consent, will be involved. Fetoscope technique will be administered in suitable patients.
Interventions
Intrauterine intervention with fetoscope technique will be applied to treat complex twin diseases with intention to improve the prognosis of patients.
Eligibility Criteria
You may qualify if:
- Pregnancy women with complicated twin diseases who are able to withstand intrauterine treatment and consent informed.
You may not qualify if:
- Pregnancy women who refuse intrauterine treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shengjing Hospital
Shenyang, Liaoning, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caixia Liu
Shengjing Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the second obstetrical department
Study Record Dates
First Submitted
August 27, 2018
First Posted
August 29, 2018
Study Start
August 31, 2018
Primary Completion
August 1, 2020
Study Completion
August 1, 2022
Last Updated
September 5, 2018
Record last verified: 2018-09
Data Sharing
- IPD Sharing
- Will not share