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

Chromosome Abnormality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02982356
• Other study ID #: ShanghaiFMIH-FMU2
• Status: Not yet recruiting
• Phase: N/A
• First received: November 29, 2016
• Last updated: December 2, 2016
• Start date: January 2017
• Est. completion date: December 2019

Study information

• Verified date: December 2016
• Source: Shanghai First Maternity and Infant Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1300
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chromosome Aberrations
• Chromosome Abnormality
• Chromosome Disorders
• Twin Pregnancy With Antenatal Problem

Intervention

Procedure:
• 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

Drug:
• Potassium Chloride

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital	Children's Hospital of Fudan University, International Peace Maternity and Child Health Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate for the operation		1 week	Yes
Secondary	long-term complications after surgery		1 year	Yes