NCT04921150

Brief Summary

At present, the incidence of monochorionic twins in all pregnancies is around 3-5‰ worldwide.In 2019, the twin Committee of China Maternal and Child Health Association conducted statistics from 48 medical units all over the country, showing that there were 4,876 cases of monochorionic twins, accounting for 10.2‰ of all pregnancies.In addition to increased incidence of preterm delivery, miscarriage, and maternal complication, the unique placental vascular structure of monochorionic twins is associated with complex fetal complication such as twin-twin transfusion syndrome, selective intraurine growth restriction, twin anaemia-erythrocytosis sequence, twin reversed arterial perfusion sequence, one of twin with dysplasia, twins with single amniotic sac and conjunctions are common. At present, there is no unified standard for the diagnosis and treatment of these complicated twins, and various treatment methods have a great impact on the pregnancy outcome and fetal prognosis.Therefore, the standardized management of complex twins benefits diagnosis and treatment of complex twins and improves fetal prognosis.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

May 26, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

3.3 years

First QC Date

May 26, 2021

Last Update Submit

June 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Standardized management system of twin pregnancy clinic

    S/D score and Apgar score of complex twin pregnancy assessed by clinical doctors

    1 year

Interventions

Apply standardization management to improve the outcomes of pregnancy

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • complex twin disease 18-45 years

You may not qualify if:

  • single pregnancy normal twin pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Caixia Liu, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

May 26, 2021

First Posted

June 10, 2021

Study Start

June 1, 2021

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

June 10, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share