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Trial Title:
The Accuracy of Ultrasound Diagnosis of Hydatidiform Moles
NCT ID:
NCT05516810
Condition:
Hydatidiform Mole (Diagnosis)
Abortion, Spontaneous
Missed Abortion
Incomplete Miscarriage
Miscarriage in First Trimester
Conditions: Official terms:
Hydatidiform Mole
Abortion, Spontaneous
Abortion, Missed
Abortion, Incomplete
Disease
Conditions: Keywords:
ultrasonography
pregnancy, first trimester
molar
miscarriage
hydatidiform
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Summary:
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.
Criteria for eligibility:
Study pop:
Women diagnosed with embryonic demise, incomplete miscarriage or suspected molar
pregnancy within two UK hospitals' early pregnancy units
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Gender:
Female
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University College London Hospital
Address:
City:
London
Zip:
NW1 2BU
Country:
United Kingdom
Facility:
Name:
King's College Hospital
Address:
City:
London
Zip:
SE5 9RS
Country:
United Kingdom
Start date:
October 19, 2021
Completion date:
September 30, 2024
Lead sponsor:
Agency:
King's College Hospital NHS Trust
Agency class:
Other
Collaborator:
Agency:
University College, London
Agency class:
Other
Source:
King's College Hospital NHS Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05516810