Diagnosis and Intervention of Complicated Twin Diseases

Study Overview
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Brief Summary
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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.

Detailed Description
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A better guideline for complicated twin diseases are anticipated to be established in China. Molecular genetics and imaging technology are applied to evaluate the outcome and prognosis of intrauterine intervention for complex twin diseases. 3D printing technology is used to assist the preoperative evaluation of fetal intrauterine intervention. Better fetal intrauterine intervention technique and prognosis evaluation are expected to be established.

Official Title
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Diagnosis and Intervention of Complicated Twin Diseases in China

Conditions
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Twin Diseases

Intervention / Treatment
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* Procedure: Fetoscope technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnancy women with complicated twin diseases who are able to withstand intrauterine treatment and consent informed. Exclusion Criteria: Pregnancy women who refuse intrauterine treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pregnancy women with complicated twin diseases, who are able to withstand risks of intrauterine treatments and informed consent.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TOCTD<br>Pregnancy 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. | Procedure: Fetoscope technique<br>* Intrauterine intervention with fetoscope technique will be applied to treat complex twin diseases with intention to improve the prognosis of patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurodevelopment at early childhood | Including adaptive, gross motor, fine motor, language, and social function; assessed using Gesell Developmental Schedules. | At age of 1 year old |