Diagnosis and Intervention of Complicated Twin Diseases

Twin Diseases Clinical Trial

Official title:

Diagnosis and Intervention of Complicated Twin Diseases in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03650985
• Other study ID #: DICTD
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2018
• Est. completion date: August 2022

Study information

• Verified date: September 2018
• Source: Shengjing Hospital
• Contact: Caixia Liu
• Phone: 86-18902451716
• Email: liucx1716[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2022
• Est. primary completion date: August 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Twin Diseases

Intervention

Procedure:
• Fetoscope technique
Intrauterine intervention with fetoscope technique will be applied to treat complex twin diseases with intention to improve the prognosis of patients.

Locations

Country	Name	City	State
China	Shengjing Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Shengjing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene expression of fetuses	DNA methylation, histone acetylation etc. assessed by analyses of fetal blood and amniotic fluid.	At 20 week of gestational age
Primary	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
Primary	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	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