Miscarriage in First TrimesterNCT06581692
Non-invasive Monitoring of Miscarriage
An observational study of Miscarriage in First Trimester, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Miscarriage in First Trimester
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2024to 31 Aug 2039
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Adult
Study population: Patients will be approached on the day of attending the early pregnancy loss clinic, and given information about the study. Sufficient time will be allowed for consideration before they confirm their decision and sign the consent. For cases with the management of ultrasound-guided manual vacuum aspiration (USG-MVA) or surgical evacuation, their remaining products of gestation will be collected for analysis.
Who may be able to join
- 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
Who cannot join
- History of psychological/ psychiatric problem
- Patient refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Hong Kong
Jacqueline Pui Wah CHUNG, MBBS, 30501537, jacquelinechung@cuhk.edu.hk
About this study
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.
Read the 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.
- Conditions
- Miscarriage in First Trimester
- Being tested
- This is a routine procedure, no intervention will be provided.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a routine procedure, no intervention will be provided.Other
This is a routine procedure, no intervention will be provided.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell-free DNA (cfDNA)
Determine the use of cfDNA to ascertain chromosomal causes of miscarriages
Measured: 15 weeks
Secondary outcomes (2)
Level of cell-free DNA
To determine the level of cell-free DNA (cfDNA) in early pregnancy
Measured: 15 weeks
Aneuploidy results from product of conception
To compare the aneuploidy results from product of conception (POC), in concordance with standard karyotyping.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start1 Sep 2024
- Primary completion31 Aug 2039 (estimated)
- Study completion31 Aug 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Miscarriage in First TrimesterStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung Pui Wah Jacqueline, Chinese University of Hong Kong
- Investigators
- PUI WAH JACQUELINE CHUNG, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581692
- Sponsor's protocol ID
- 2024.354
- Status last verified
- Nov 2024
- First submitted
- 23 Aug 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Monitoring of Miscarriage
- ClinicalTrials.gov ID
- NCT06581692
- Acronym / sponsor ID
- 2024.354
- Conditions
- Miscarriage in First Trimester
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Aug 2039 (estimated)
- Study completion
- 31 Aug 2039 (estimated)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients will be approached on the day of attending the early pregnancy loss clinic, and given information about the study. Sufficient time will be allowed for consideration before they confirm their decision and sign the consent. For cases with the management of ultrasound-guided manual vacuum aspiration (USG-MVA) or surgical evacuation, their remaining products of gestation will be collected for analysis.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- History of psychological/ psychiatric problem
- Patient refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a routine procedure, no intervention will be provided.This is a routine procedure, no intervention will be provided. | Other | – |
Primary outcome
Cell-free DNA (cfDNA)
Time frame: 15 weeks
Determine the use of cfDNA to ascertain chromosomal causes of miscarriages
2 secondary outcomes
Level of cell-free DNA
Time frame: 15 weeks
Aneuploidy results from product of conception
Time frame: 15 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Miscarriage in First Trimester
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GRACE - Genetic Insights Into Early pRegnancy Loss Using Cell-free fEtal DNA
Miscarriage in First Trimester, Prenatal Genetic Diagnosis
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Hysteroscopic Resection Versus Manual Vacuum Aspiration for Early Pregnancy
Miscarriage in First Trimester
Recruiting
Success Rates of Expectant vs. Medical Management for Retained Products After First-Trimester Abortion: Randomized Controlled Trial
Retained Product of Conception After First Trimester Medical Abortion
RecruitingObservational study
Comprehensive Assessment of First Trimester Pregnancy Loss
Miscarriage in First Trimester
RecruitingPhase 4
Letrozole Plus Misoprostol Versus Misoprostol Alone for Treating Women With Missed Miscarriage
Miscarriage in First Trimester, Missed Miscarriage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
PUI WAH JACQUELINE CHUNG principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Miscarriage in First Trimester, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact PUI WAH JACQUELINE CHUNG (+852 35051764, jacquelinechung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cell-free DNA (cfDNA) (time frame: 15 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.