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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02982356
Other study ID # ShanghaiFMIH-FMU2
Secondary ID
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


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
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