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

Shanghai First Maternity and Infant Hospital

Status: Unknown

Conditions: Chromosome Abnormality; Twin Pregnancy With Antenatal Problem

Treatments: Drug: Potassium Chloride; Procedure: Fetal Selective Reduction Technology

Study type: Interventional

Funder types: Other

Identifiers

NCT02982356

ShanghaiFMIH-FMU2

Details and patient eligibility

About

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

Enrollment: 1,300 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,300 participants in 2 patient groups

Fetal Selective Reduction Technology

Other group

Description:

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

Treatment:

Drug: Potassium Chloride

Procedure: Fetal Selective Reduction Technology

control group

No Intervention group

Description:

normal dichorial twins without any intervention