NCT02956564

Brief Summary

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.

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
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

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 2, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2016

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

December 12, 2016

Status Verified

November 1, 2016

Enrollment Period

1.7 years

First QC Date

November 2, 2016

Last Update Submit

December 9, 2016

Conditions

Fetal Hydrops

Outcome Measures

Primary Outcomes (1)

  • Neonatal mortality

    1 year

Secondary Outcomes (1)

  • Success rate for the operation

    1 week

Study Arms (2)

exposure group

OTHER

subjects in this group are those who accept intrauterine intervention

Procedure: intrauterine intervention

control group

NO INTERVENTION

subjects in this group are those who do not accept intrauterine intervention

Interventions

intrauterine interventionPROCEDURE

choose different surgeries according to different causes

exposure group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hydrops Fetalis

Condition Hierarchy (Ancestors)

Erythroblastosis, FetalFetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHematologic DiseasesHemic and Lymphatic Diseasesalpha-ThalassemiaThalassemiaHemoglobinopathiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, InbornImmune System DiseasesEdemaSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

November 2, 2016

First Posted

November 7, 2016

Study Start

December 1, 2016

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

December 12, 2016

Record last verified: 2016-11