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Status unknownNCT02982356Updated Dec 5, 2016

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

An interventional study of Fetal Selective Reduction Technology and Potassium Chloride in Chromosome Abnormality and Twin Pregnancy With Antenatal Problem, sponsored by Shanghai First Maternity and Infant Hospital. Status unknown. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-12-05.

Sponsored by Shanghai First Maternity and Infant Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,300
Allocation
Non-randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study 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
02

Conditions studied

  • Chromosome Abnormality
  • Twin Pregnancy With Antenatal Problem

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03

In context

Chromosome Aberrations

58 studies on the registry are indexed under Chromosome Aberrations; 13 are open to participants now.

This study's planned enrollment of 1,300 is above the median of 260 across 15 interventional studies indexed under Chromosome Aberrations.

Browse Chromosome Aberrations studies →

Lead sponsor

Shanghai First Maternity and Infant Hospital is the lead sponsor of 48 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Multiple pregnancies (three or more)
  • Maternal history of chromosome aneuploidy abnormality or tumor
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,300 participants (estimated)

Study arms

  • Other
    Fetal Selective Reduction Technology

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

    Procedure: Fetal Selective Reduction Technology · Drug: Potassium Chloride

  • No intervention
    control group

    normal dichorial twins without any intervention

Interventions

  • ProcedureFetal 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

06

What researchers measure

Primary outcomes

  1. Success rate for the operation

    Time frame: 1 week

Secondary outcomes

  1. long-term complications after surgery

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — The Individual Participant Data sharing plan will be discussed with the other collaborators

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02982356
Lead sponsor
Shanghai First Maternity and Infant Hospital
Collaborators
Children's Hospital of Fudan University, International Peace Maternity and Child Health Hospital
Responsible party
Sponsor
First posted
Dec 5, 2016
Start date
Jan 2017
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Dec 5, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Potassium Chloride

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