NCT02982356

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. 1.to explore a suitable, early, noninvasive and accurate prenatal screening strategy for twin pregnancy.
  2. 2.fetal chromosomal abnormalities

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 5, 2016

Status Verified

December 1, 2016

Enrollment Period

2.9 years

First QC Date

November 29, 2016

Last Update Submit

December 2, 2016

Conditions

Chromosome AbnormalityTwin Pregnancy With Antenatal Problem

Outcome Measures

Primary Outcomes (1)

  • Success rate for the operation

    1 week

Secondary Outcomes (1)

  • long-term complications after surgery

    1 year

Study Arms (2)

Fetal Selective Reduction Technology

OTHER

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

Procedure: Fetal Selective Reduction TechnologyDrug: Potassium Chloride

control group

NO INTERVENTION

normal dichorial twins without any intervention

Interventions

Fetal Selective Reduction TechnologyPROCEDURE

Fetal Selective Reduction Technology will be conducted according to different gestational weeks: before 16weeks, 16\~24 weeks, 24\~27+6 weeks,\>28weeks

Fetal Selective Reduction Technology
Potassium ChlorideDRUG
Fetal Selective Reduction Technology

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ultrasound diagnosis as twin pregnancy
  • at 11-14 gestational weeks

You may not qualify if:

  • Multiple pregnancies (three or more)
  • Maternal history of chromosome aneuploidy abnormality or tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chromosome Aberrations

Interventions

Potassium Chloride

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsPotassium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2016

First Posted

December 5, 2016

Study Start

January 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

December 5, 2016

Record last verified: 2016-12