NCT04952415

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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jul 2021Jul 2026

First Submitted

Initial submission to the registry

June 27, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 7, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

July 7, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

June 27, 2021

Last Update Submit

June 27, 2021

Conditions

Keywords

TTTS

Outcome Measures

Primary Outcomes (1)

  • Weight in kilogram of neonate

    Including twin pregnancy of TTTS after fetoscopic laser surgery measured by nurses

    At birth of neonate

Secondary Outcomes (1)

  • Neurodevelopment at early childhood

    At age of 1 year old

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

TTTS after fetoscopic laser surgery.

You may qualify if:

  • TTTS after fetoscopic laser surgery.

You may not qualify if:

  • Pregnant women who refuse to take part in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Conditions

Diseases in Twins

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the second obstetrical department

Study Record Dates

First Submitted

June 27, 2021

First Posted

July 7, 2021

Study Start

July 1, 2021

Primary Completion

July 1, 2022

Study Completion (Estimated)

July 1, 2026

Last Updated

July 7, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations