Diagnosis and Intervention of Complicated Twin Diseases
- Conditions
- Twin Diseases
- Interventions
- Procedure: Fetoscope technique
- Registration Number
- NCT03650985
- Lead Sponsor
- Shengjing Hospital
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
- Pregnancy women with complicated twin diseases who are able to withstand intrauterine treatment and consent informed.
- Pregnancy women who refuse intrauterine treatment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TOCTD Fetoscope technique 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.
- Primary Outcome Measures
Name Time Method Change of volume of amniotic fluid in Milliliter At every two week from the sixteenth week of gestational age to delivery of babies Measured by doctors of sonography
Change of umbilical artery blood flow At every two week from the sixteenth week of gestational age to delivery of babies Measured by doctors of sonography
Gene expression of fetuses At 20 week of gestational age DNA methylation, histone acetylation etc. assessed by analyses of fetal blood and amniotic fluid.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Shengjing Hospital
🇨🇳Shenyang, Liaoning, China