Actively Recruiting

Age: 18Years - 45Years
All Genders
ID06581692

Non-invasive Monitoring of Miscarriage

Led by Chinese University of Hong Kong · Updated on 2024-11-12

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research focuses on miscarriage in the first trimester, particularly examining the usefulness of cell-free DNA (cfDNA) in early pregnancy. The study aims to determine cfDNA levels and compare these results with product of conception (POC) testing and standard karyotyping. It highlights that pregnancies achieved by assisted reproductive technologies (ART) are closely monitored, while spontaneous abortion rates in natural conceptions are harder to assess. Women undergoing ART may have a higher vulnerability to miscarriage, making this research important for understanding chromosomal causes. Participants will not receive any treatment or intervention as this is an observational study involving routine procedures. The study involves monitoring and testing cfDNA levels and comparing these with genetic analysis of pregnancy tissue. The primary and secondary outcome measures will be evaluated at 15 weeks of pregnancy. During the study, women attending early pregnancy loss clinics or those who have received ART, along with their partners, will have their cfDNA levels measured and compared to POC testing results. Researchers will collect data through blood tests and genetic analyses without providing interventions. The total participation timeline includes assessments up to 15 weeks of pregnancy to monitor cfDNA and aneuploidy results, ensuring close observation of early pregnancy loss.

CONDITIONS

Brief Title

Non-invasive Monitoring of Miscarriage

Who Can Participate

Age: 18Years - 45Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-45 years
  • Women who attend the early pregnancy loss clinic or patients who receive assisted reproductive technology (ART)
  • Biological partners of the pregnancy
Not Eligible

You will not qualify if you...

  • History of psychological or psychiatric problems
  • Patient refusal

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 15 weeks

Participants undergo blood tests to measure cell-free DNA levels and product of conception testing in early pregnancy loss.

1 to 2 visits depending on pregnancy status

Long-term Monitoring

Duration - Up to 15 weeks

Participants are observed to collect data on miscarriage outcomes and cfDNA levels over time without additional intervention.

Follow-up visits as needed during the observation period

Trial Site Locations

Total: 1 location

1

Prince of Wales Hospital

Hong Kong, Hong Kong

Actively Recruiting

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Research Team

P

PUI WAH JACQUELINE CHUNG

Y

Yee Lee Elaine NG

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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