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

Not Applicable

• Conditions: Chromosome Abnormality; Twin Pregnancy With Antenatal Problem
• Interventions: Procedure: Fetal Selective Reduction Technology; Drug: Potassium Chloride

• Registration Number: NCT02982356
• Lead Sponsor: Shanghai First Maternity and Infant Hospital

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2016-11-29
• Status Verified: 2016-12
• Study First Submitted QC: 2016-12-02
• Last Update Submitted: 2016-12-02
• Study First Posted: 2016-12-05
• Last Update Posted: 2016-12-05
• Study Start: 2017-01
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fetal Selective Reduction Technology	Fetal Selective Reduction Technology	Potassium chloride fetal heart injection in the dichorial twins with abnormal chromosome and structure
Fetal Selective Reduction Technology	Potassium Chloride	Potassium chloride fetal heart injection in the dichorial twins with abnormal chromosome and structure

Primary Outcome Measures

Name	Time	Method
Success rate for the operation	1 week

Secondary Outcome Measures

Name	Time	Method
long-term complications after surgery	1 year