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

• Sponsor: Shanghai First Maternity and Infant Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02982356
• Collaborator: Children's Hospital of Fudan University (Other), International Peace Maternity and Child Health Hospital (Other)
• Enrollment: 1,300
• Arms: 2
• Duration (Months): 35

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chromosome Abnormality; Twin Pregnancy With Antenatal Problem	Procedure: Fetal Selective Reduction Technology; Drug: Potassium Chloride	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1300 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prenatal Screening, Diagnosis and Intrauterine Intervention of Fetal Abnormal Chromosome and Structure in Twins Pregnancy
• Study Start Date: Jan 1, 2017
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Fetal Selective Reduction Technology Potassium chloride fetal heart injection in the dichorial twins with abnormal chromosome and structure	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
No Intervention: control group normal dichorial twins without any intervention

Outcome Measures

Primary Outcome Measures

1. Success rate for the operation [1 week]

Secondary Outcome Measures

1. long-term complications after surgery [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shanghai First Maternity and Infant Hospital
• Children's Hospital of Fudan University
• International Peace Maternity and Child Health Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai First Maternity and Infant Hospital
• ClinicalTrials.gov Identifier: NCT02982356
• Other Study ID Numbers: ShanghaiFMIH-FMU2
• First Posted: Dec 5, 2016
• Last Update Posted: Dec 5, 2016
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Chromosome Disorders; Chromosome Aberrations

Study Results

No Results Posted as of Dec 5, 2016