Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment

December 9, 2016 updated by: Shanghai First Maternity and Infant Hospital
Based on multi-center clinical research resources, a large-scale prospective cohort study will be conduted to make a more accurate diagnosis and intervention plan of Non-immune fetal hydrops (NIFH), and then establish NIFH accurate treatment strategy which is suitable for China's national conditions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

  1. Etiological study of Non-immune fetal hydrops(NIFH):

    1. Etiological study of NIFH in mid-pregnancy period;
    2. Etiological study of NIFH and hygroma colli in first trimester;
    3. Value assessment of technology for exome sequencing in diagnosis of NIFH;

  2. The accuracy of NIFH intrauterine intervention and its effect assessment:

    1. Perinatal outcomes of NIFH ;
    2. The effect of intrauterine treatments.

Study Type

Interventional

Enrollment (Anticipated)

144

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:

  • Cases corresponding to diagnosis standards
  • Willing to accept the regular follow-up

Exclusion Criteria:

  • Immune hydrops fetalis
  • Multiple pregnancy, except for twin-to-twin transfusion syndrome IV

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: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: exposure group
subjects in this group are those who accept intrauterine intervention
Procedure: intrauterine intervention
choose different surgeries according to different causes
No Intervention: control group
subjects in this group are those who do not accept intrauterine intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Neonatal mortality
Time Frame: 1 year
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Shanghai First Maternity and Infant Hospital

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

December 1, 2016

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

August 1, 2018

Study Registration Dates

First Submitted

November 2, 2016

First Submitted That Met QC Criteria

November 3, 2016

First Posted (Estimate)

November 6, 2016

Study Record Updates

Last Update Posted (Estimate)

December 12, 2016

Last Update Submitted That Met QC Criteria

December 9, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShanghaiFMIH-FMU1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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