the Prognosis of Fetoscopy Treatment of Twin Transfusion Syndrome

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Twin Diseases

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110004
      • Shengjing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

TTTS after fetoscopic laser surgery.

Description

Inclusion Criteria:

TTTS after fetoscopic laser surgery.

Exclusion Criteria:

Pregnant women who refuse to take part in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight in kilogram of neonate	Including twin pregnancy of TTTS after fetoscopic laser surgery measured by nurses	At birth of neonate

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

Collaborators and Investigators

• Sponsor: Shengjing Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2026

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: June 27, 2021
• First Posted (Actual): July 7, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: June 27, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: TTTS
• Additional Relevant MeSH Terms: Hematologic Diseases; Infant, Newborn, Diseases; Anemia; Anemia, Neonatal; Fetofetal Transfusion
• Other Study ID Numbers: PFTTTTS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No