The Accuracy of Ultrasound Diagnosis of Hydatidiform Moles

NCT05516810 | Active Not Recruiting

• 1 other identifier: 136133
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

This is a prospective observational study assessing which ultrasound findings are best at excluding a molar pregnancy in first trimester miscarriage.

Conditions

Hydatidiform Mole (Diagnosis); Abortion, Spontaneous; Missed Abortion; Incomplete Miscarriage; Miscarriage in First Trimester

Keywords

ultrasonography; pregnancy, first trimester; molar; miscarriage; hydatidiform

Outcome Measures

Primary Outcomes (2)

• histological diagnosis of molar pregnancy yes / no

  binary outcome measure

  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

  up to 2 months post miscarriage

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• University College, London: collaborator

Study Sites (2)

University College London Hospital

London, NW1 2BU, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Hydatidiform Mole; Disease; Abortion, Spontaneous; Abortion, Missed; Abortion, Incomplete

Condition Hierarchy (Ancestors)

Gestational Trophoblastic Disease; Trophoblastic Neoplasms; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Pregnancy Complications, Neoplastic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jackie Ross, MD

  King's College Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 26, 2022
• Study Start: October 19, 2021
• Primary Completion: May 5, 2024
• Study Completion: September 30, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)