Non-invasive Monitoring of Miscarriage
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: This is a routine procedure, no intervention will be provided..
- Who it may be relevant to
- Registry conditions: Miscarriage in First Trimester. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
cfDNA is extremely useful to ascertain chromosomal causes of miscarriages at the point of miscarriage diagnosis by a simple blood test. This study aims to determine the level of cell-free DNA (cfDNA) in early pregnancy and compare the results with those of product of conception (POC) testing, in concordance with standard karyotyping.
Detailed description
Pregnancies achieved by assisted reproductive technologies (ART) are closely monitored, therefore miscarriages that occur very early in the pregnancy are frequently meticulously recorded and reported. On the other hand, spontaneous abortion rates among naturally occurring conceptions are notoriously hard to quantify and are often overstated when using criteria from assisted reproductive technologies. Additionally, women who have undergone treatment with ART are a particular population with traits that can make them more vulnerable to spontaneous abortions.
cfDNA would be extremely useful to ascertain chromosomal causes of miscarriages at the point of miscarriage diagnosis by a simple blood test. This study aims to determine the level of cell-free DNA (cfDNA) in early pregnancy and compare the results with those of product of conception (POC) testing, in concordance with standard karyotyping.
Interventions
- Other This is a routine procedure, no intervention will be provided.
This is a routine procedure, no intervention will be provided.
Primary outcome measures
- Cell-free DNA (cfDNA) [Time frame: 15 weeks]
Secondary outcome measures (2)
- Level of cell-free DNA [Time frame: 15 weeks]
- Aneuploidy results from product of conception [Time frame: 15 weeks]
Eligibility criteria
Inclusion criteria
- Age 18-45 years.
- Women who attend the early pregnancy loss clinic or Patients who receive ART
- Their partner, the biological father of the pregnancy
Exclusion criteria
- History of psychological/ psychiatric problem
- Patient refusal
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Hong Kong · 1 center
- Prince of Wales Hospital — Hong Kong
Identifiers
NCT: NCT06581692 · 2024.354