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

Fetal Hydrops Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02956564
• Other study ID #: ShanghaiFMIH-FMU1
• Status: Not yet recruiting
• Phase: N/A
• First received: November 2, 2016
• Last updated: December 9, 2016
• Start date: December 2016
• Est. completion date: August 2018

Study information

• Verified date: November 2016
• Source: Shanghai First Maternity and Infant Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Shanghai Municipal Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Fetal Hydrops
• Hydrops Fetalis

Intervention

Procedure:
• intrauterine intervention
choose different surgeries according to different causes

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai First Maternity and Infant Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal mortality		1 year	No
Secondary	Success rate for the operation		1 week	No