Hydatidiform Mole (Diagnosis)NCT05516810
The Accuracy of Ultrasound Diagnosis of Hydatidiform Moles
An observational study of Hydatidiform Mole (Diagnosis) and Abortion, Spontaneous, run by King's College Hospital NHS Trust at 2 sites in United Kingdom.
Trial summary
This is a prospective observational study assessing which ultrasound findings are best at excluding a molar pregnancy in first trimester miscarriage. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Hydatidiform Mole (Diagnosis), Abortion, Spontaneous, Missed Abortion
- How many people
- 500 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 19 Oct 2021to 30 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women diagnosed with embryonic demise, incomplete miscarriage or suspected molar pregnancy within two UK hospitals' early pregnancy units
Who may be able to join
- less than 16 weeks gestation by last menstrual period or by ultrasound
- singleton pregnancy
- ultrasound diagnosis of early embryonic demise or incomplete miscarriage or suspected molar pregnancy.
Who cannot join
- Women declining participation and follow up
- Women who refuse transvaginal scan
- Multiple pregnancy
- Ectopic pregnancy
- Pregnancy of unknown location
- Those unable to understand English to an adequate degree to understand and consent to participation in this study
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University College London Hospital
London, NW1 2BU
King's College Hospital
London, SE5 9RS
About this study
This is a prospective observational study assessing which ultrasound findings are best at excluding a molar pregnancy in first trimester miscarriage.
Read the detailed description
The objectives of this study are to establish the accuracy of ultrasound for the diagnosis of HMs, assess prevalence of these ultrasound features in early pregnancy failure (missed-miscarriages and incomplete miscarriages), and establish which ultrasound signs are the best predictor of HMs on histopathology. The findings of this study will allow us to improve the early diagnosis of HMs by ultrasound therefore allowing us to tailor our counselling and clinical management.
All women attending the EPUs and with findings of an early embryonic demise or incomplete miscarriage on transvaginal scan (either by dates or by scan findings) will be eligible to take part in the study. The NICE criteria to diagnose miscarriage will be used.
Diagnostic criteria derived from retrospective studies will be used to make the diagnosis of suspected HMs on ultrasound and the presence or absence of these features specifically noted. All participants will be scanned by specialist Gynaecologists who are members of the research team, or the direct clinical care team.
Women with suspected HMs on ultrasound will be advised to undergo surgical management of miscarriage, which is in line with current national clinical guidance and maximises the chance of histological diagnosis. All other participants will be offered surgical, medical or expectant management as per standard clinical practice. All women who opt for surgical management, or in whom any pregnancy tissue is available, will have their pregnancy tissue sent for histology, as per national guidance. We will then compare the ultrasound findings with the final histological diagnosis for those women with histopathology specimens and will phone those participants without histopathology specimens to check that their pregnancy tests have reverted to negative 3 weeks after their miscarriage so as to exclude persistent GTN as per standard clinical practice. In addition to this we will perform a blood test for checking pregnancy hormones, beta HCG to assess the correlation between these levels and histologically diagnosed hydatiform moles.
All eligible women will be invited to participate in the study and be provided with written consent to have their clinical data included in the study following their ultrasound scan.
Participation in the study will be voluntary and refusal to participate will not affect patients' care. Furthermore, taking part in the study will involve an additional blood test, but no other additional interventions over their routine clinical care; however, it will include personal data collection for the purpose of the study. All identifiable data will be anonymised.
- Conditions
- Hydatidiform Mole (Diagnosis), Abortion, Spontaneous, Missed Abortion, Incomplete Miscarriage, Miscarriage in First Trimester
- Keywords
- ultrasonography, pregnancy, first trimester, molar, miscarriage, hydatidiform
- Medical subject headings
- Hydatidiform Mole, Disease, Abortion, Spontaneous, Abortion, Missed, Abortion, Incomplete
What is being measured
The primary outcome is the main question the study is designed to answer.
histological diagnosis of molar pregnancy yes / no
binary outcome measure
Measured: within a month post miscarriage
hCG undetectable in the urine yes / no
Negative pregnancy test post miscarriage for those with no tissue available for histology
Measured: up to 2 months post miscarriage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start19 Oct 2021
- Primary completion5 May 2024
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hydatidiform Mole (Diagnosis)Studies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University College, London
- Responsible party
- Sponsor
- Investigators
- Jackie Ross, MD, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516810
- Sponsor's protocol ID
- 136133
- Status last verified
- Jun 2024
- First submitted
- 27 Jul 2022
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share participant data with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Accuracy of Ultrasound Diagnosis of Hydatidiform Moles
- ClinicalTrials.gov ID
- NCT05516810
- Acronym / sponsor ID
- 136133
- Conditions
- Hydatidiform Mole (Diagnosis), Abortion, Spontaneous, Missed Abortion, Incomplete Miscarriage, Miscarriage in First Trimester
- Keywords
- ultrasonography, pregnancy, first trimester, molar, miscarriage, hydatidiform
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- University College, London
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 5 May 2024 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 26 Aug 2022 (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.
This is a prospective observational study assessing which ultrasound findings are best at excluding a molar pregnancy in first trimester miscarriage.
Detailed description
The objectives of this study are to establish the accuracy of ultrasound for the diagnosis of HMs, assess prevalence of these ultrasound features in early pregnancy failure (missed-miscarriages and incomplete miscarriages), and establish which ultrasound signs are the best predictor of HMs on histopathology. The findings of this study will allow us to improve the early diagnosis of HMs by ultrasound therefore allowing us to tailor our counselling and clinical management.
All women attending the EPUs and with findings of an early embryonic demise or incomplete miscarriage on transvaginal scan (either by dates or by scan findings) will be eligible to take part in the study. The NICE criteria to diagnose miscarriage will be used.
Diagnostic criteria derived from retrospective studies will be used to make the diagnosis of suspected HMs on ultrasound and the presence or absence of these features specifically noted. All participants will be scanned by specialist Gynaecologists who are members of the research team, or the direct clinical care team.
Women with suspected HMs on ultrasound will be advised to undergo surgical management of miscarriage, which is in line with current national clinical guidance and maximises the chance of histological diagnosis. All other participants will be offered surgical, medical or expectant management as per standard clinical practice. All women who opt for surgical management, or in whom any pregnancy tissue is available, will have their pregnancy tissue sent for histology, as per national guidance. We will then compare the ultrasound findings with the final histological diagnosis for those women with histopathology specimens and will phone those participants without histopathology specimens to check that their pregnancy tests have reverted to negative 3 weeks after their miscarriage so as to exclude persistent GTN as per standard clinical practice. In addition to this we will perform a blood test for checking pregnancy hormones, beta HCG to assess the correlation between these levels and histologically diagnosed hydatiform moles.
All eligible women will be invited to participate in the study and be provided with written consent to have their clinical data included in the study following their ultrasound scan.
Participation in the study will be voluntary and refusal to participate will not affect patients' care. Furthermore, taking part in the study will involve an additional blood test, but no other additional interventions over their routine clinical care; however, it will include personal data collection for the purpose of the study. All identifiable data will be anonymised.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women diagnosed with embryonic demise, incomplete miscarriage or suspected molar pregnancy within two UK hospitals' early pregnancy units
Key inclusion criteria (3 listed)
- less than 16 weeks gestation by last menstrual period or by ultrasound
- singleton pregnancy
- ultrasound diagnosis of early embryonic demise or incomplete miscarriage or suspected molar pregnancy.
Key exclusion criteria (6 listed)
- Women declining participation and follow up
- Women who refuse transvaginal scan
- Multiple pregnancy
- Ectopic pregnancy
- Pregnancy of unknown location
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
histological diagnosis of molar pregnancy yes / no
Time frame: within a month post miscarriage
binary outcome measure
hCG undetectable in the urine yes / no
Time frame: up to 2 months post miscarriage
Negative pregnancy test post miscarriage for those with no tissue available for histology
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No. no plan to share participant data with other researchers
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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. This study is not recruiting at the moment.
Jackie Ross, MD principal investigator
King's College Hospital NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydatidiform Mole (Diagnosis) and Abortion, Spontaneous, run by King's College Hospital NHS Trust at 2 sites in United Kingdom.
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 6 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: status not confirmed, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
histological diagnosis of molar pregnancy yes / no (time frame: within a month post miscarriage). The study lists 2 primary outcomes in all. 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 11 Jun 2024.