the Prognosis of Fetoscopy Treatment of Twin Transfusion Syndrome

Twin Diseases Clinical Trial

Official title:

the Prognosis of Fetoscopy Treatment of Twin Transfusion Syndrome in Shengjing Hospital

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04952415
• Other study ID #: PFTTTTS
• Status: Not yet recruiting
• Start date: July 1, 2021
• Est. completion date: July 1, 2026

Study information

• Verified date: June 2021
• Source: Shengjing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

TTTS after fetoscopic laser surgery. Exclusion Criteria: Pregnant women who refuse to take part in the study

Related Conditions & MeSH terms

• Fetofetal Transfusion
• Twin Diseases

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	Weight in kilogram of neonate	Including twin pregnancy of TTTS after fetoscopic laser surgery measured by nurses	At birth of neonate
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