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

Shanghai First Maternity and Infant Hospital

Status: Unknown

Conditions: Fetal Hydrops

Treatments: Procedure: intrauterine intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02956564

ShanghaiFMIH-FMU1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

exposure group

Other group

Description:

subjects in this group are those who accept intrauterine intervention

Treatment:

Procedure: intrauterine intervention

control group

No Intervention group

Description:

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