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

• ClinicalTrials.gov Identifier: NCT02956564
• Recruitment Status: Unknown
• First Posted: November 6, 2016
• Last Update Posted: December 12, 2016
• Sponsor: Shanghai First Maternity and Infant Hospital
• Information provided by (Responsible Party): Shanghai First Maternity and Infant Hospital

Tracking Information

• First Submitted Date: November 2, 2016
• First Posted Date: November 6, 2016
• Last Update Posted Date: December 12, 2016
• Study Start Date: December 2016
• Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 3, 2016): Neonatal mortality [ Time Frame: 1 year ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: November 3, 2016): Success rate for the operation [ Time Frame: 1 week ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment
• Official Title: Precision Medical Research of Non-immune Fetal Hydrops (NIFH)-From Prenatal Diagnosis to Intrauterine Treatment
• 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.

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
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Fetal Hydrops

Intervention

Procedure: intrauterine intervention

choose different surgeries according to different causes

Study Arms

• exposure group
  subjects in this group are those who accept intrauterine intervention
  Intervention: Procedure: intrauterine intervention
• No Intervention: control group
  subjects in this group are those who do not accept intrauterine intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 3, 2016): 144
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: August 2018
• Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT02956564
• Other Study ID Numbers: ShanghaiFMIH-FMU1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Shanghai First Maternity and Infant Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Shanghai First Maternity and Infant Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Shanghai First Maternity and Infant Hospital
• Verification Date: November 2016