NCT04966039

Brief Summary

Diffusion weighted imaging (DWI) can reflect the microstructure and pathological changes of tissue, and diffusion tensor imaging (DTI) can quantitatively evaluate the fine structure of white matter in brain. In this study, conventional and diffusion-weighted MRI (DWI, DTI) sequences were used to analyze the brain of monochorionic twin pregnancies with demise of one fetus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 19, 2021

Completed
Last Updated

July 19, 2021

Status Verified

June 1, 2021

Enrollment Period

3 years

First QC Date

June 29, 2021

Last Update Submit

July 14, 2021

Conditions

Twin Pregnancy With Antenatal Problem

Keywords

twin pregnancydemise of one fetusDiffusion weighted imagingDiffusion tensor imaging

Outcome Measures

Primary Outcomes (8)

  • basic information

    age

    baseline

  • basic information

    gestational age

    baseline

  • basic information

    uterine height

    baseline

  • basic information

    abdominal circumference

    baseline

  • basic information

    intrauterine death time of one fetus

    baseline

  • MRI

    DWI sequence (ADC value)

    baseline

  • MRI

    DTI sequence (FA value)

    baseline

  • MRI

    conventional sequence

    baseline

Study Arms (3)

monochorionic twin pregnancies with demise of one fetus

Twin pregnancy was diagnosed and one fetus died in utero, 20 pregnant women

Other: No intervention.

Twin control group

Twin pregnancy with one abnormal fetus, 20 pregnant women

Other: No intervention.

Singleton control group

Singleton pregnancy with abnormalities outside the fetal brain, 20 pregnant women

Other: No intervention.

Interventions

No intervention.OTHER

There was no intervention.

Singleton control groupTwin control groupmonochorionic twin pregnancies with demise of one fetus

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Twin pregnancy was diagnosed and one fetus died in utero 2. Twin pregnancy with one abnormal fetus 3. Singleton pregnancy with abnormalities outside the fetal brain

You may qualify if:

  • Twin pregnancy was diagnosed and one fetus died in utero
  • Twin pregnancy with one abnormal fetus
  • Singleton pregnancy with abnormalities outside the fetal brain

You may not qualify if:

  • Those who can't cooperate with MRI examination, such as those who have metal, claustrophobia or can't insist on scanning.
  • Pregnant women with gestational age less than 20 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

Study Officials

  • Ying Liu, Dr.

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2021

First Posted

July 19, 2021

Study Start

January 1, 2018

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

July 19, 2021

Record last verified: 2021-06

Locations

CN(1)