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

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

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

1300

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Fetal Selective Reduction Technology
Potassium chloride fetal heart injection in the dichorial twins with abnormal chromosome and structure
Fetal Selective Reduction Technology will be conducted according to different gestational weeks: before 16weeks, 16~24 weeks, 24~27+6 weeks,>28weeks
NO_INTERVENTION: control group
normal dichorial twins without any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success rate for the operation
Time Frame: 1 week
1 week

Secondary Outcome Measures

Outcome Measure
Time Frame
long-term complications after surgery
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

November 29, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (ESTIMATE)

December 5, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 5, 2016

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • ShanghaiFMIH-FMU2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The Individual Participant Data sharing plan will be discussed with the other collaborators

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Twin Pregnancy With Antenatal Problem

Clinical Trials on Potassium Chloride

3
Subscribe