The Accuracy of Ultrasound Diagnosis of Hydatidiform Moles

August 23, 2022 updated by: King's College Hospital NHS Trust
This is a prospective observational study assessing which ultrasound findings are best at excluding a molar pregnancy in first trimester miscarriage.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Women diagnosed with embryonic demise, incomplete miscarriage or suspected molar pregnancy within two UK hospitals' early pregnancy units

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
histological diagnosis of molar pregnancy yes / no
Time Frame: within a month post miscarriage
binary outcome measure
within a month post miscarriage
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
up to 2 months post miscarriage

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College Hospital NHS Trust

Collaborators

University College, London

Investigators

  • Principal Investigator: Jackie Ross, MD, King's College Hospital, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2021

Primary Completion (Anticipated)

June 5, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

July 27, 2022

First Submitted That Met QC Criteria

August 23, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 23, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 136133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

no plan to share participant data with other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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