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Prenatal Screening, Diagnosis and Intrauterine Intervention of Fetal Abnormal Chromosome and Structure in Twins Pregnancy

NCT ID: NCT02982356

Last Updated: 2016-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-12-31

Brief Summary

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The risk of abnormal chromosome and structure is much higher in twins than in singletons, and traditional early pregnancy screening strategy for single pregnancy is not suitable for twins. Based on our management experience of fetal medicine at twin pregnancy, and multi-center cooperation, the study will carry out the following clinical studies:

1. to explore a suitable, early, noninvasive and accurate prenatal screening strategy for twin pregnancy.
2. fetal chromosomal abnormalities

Detailed Description

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Conditions

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Chromosome Abnormality Twin Pregnancy With Antenatal Problem

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fetal Selective Reduction Technology

Potassium chloride fetal heart injection in the dichorial twins with abnormal chromosome and structure

Group Type OTHER

Fetal Selective Reduction Technology

Intervention Type PROCEDURE

Fetal Selective Reduction Technology will be conducted according to different gestational weeks: before 16weeks, 16\~24 weeks, 24\~27+6 weeks,\>28weeks

Potassium Chloride

Intervention Type DRUG

control group

normal dichorial twins without any intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fetal Selective Reduction Technology

Fetal Selective Reduction Technology will be conducted according to different gestational weeks: before 16weeks, 16\~24 weeks, 24\~27+6 weeks,\>28weeks

Intervention Type PROCEDURE

Potassium Chloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ultrasound diagnosis as twin pregnancy
* at 11-14 gestational weeks

Exclusion Criteria

* Multiple pregnancies (three or more)
* Maternal history of chromosome aneuploidy abnormality or tumor
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role collaborator

International Peace Maternity and Child Health Hospital

OTHER

Sponsor Role collaborator

Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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ShanghaiFMIH-FMU2

Identifier Type: -

Identifier Source: org_study_id