Angular Pregnancy - Ultrasound Definition and Correlation With Clinical Outcomes

February 6, 2024 updated by: King's College Hospital NHS Trust

Are Early Pregnancies Implanted Close to the Tubal Ostia at Increased Risk of Miscarriage? A Prospective Observational Study

The aim of this study is to establish clinically meaningful ultrasound-based diagnostic criteria for AP. To this end, the investigators will prospectively collect clinical and ultrasound data from early intrauterine pregnancies and correlate this data with pregnancy outcomes (particularly with risk of miscarriage), to establish whether there are any diagnostic criteria that can be used to make the diagnosis, facilitate increased surveillance of at risk pregnancies and reassure those with normally located pregnancies. The collected data will be used to correlate incidence of angular pregnancy and clinical variables such as maternal age, uterine fibroids, assisted conception, multiple pregnancy, ethnicity, previous uterine and adnexal surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

236

Contacts and Locations

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

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • King's College Hospital

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pregnant women who are attending for a scan in the early pregnancy unit, aged over 16 years.

Description

Inclusion Criteria:

  • Have capacity to understand the study and to provide signed and dated informed consent.
  • Willing to comply with all study procedures and be available for the duration of the study including consenting to follow up of the pregnancy outcome by letter, phone or email according to individual preference.
  • Age 16 years or over
  • Mean gestational sac diameter (GSD) on ultrasound of 2-15mm inclusive
  • GS implantation site within the upper half of the uterine cavity on 2D USS

Exclusion Criteria:

  • Women with pregnancies of unknown location, ectopic pregnancies or larger GSD than specified in the inclusion criteria.
  • Implantation site within the lower half of the endometrial cavity on 2D USS screening.
  • Intention to terminate the pregnancy
  • Women with unicornuate uteri or unicornuate uteri with rudimentary horns
  • Women with uterine fibroids which distort the uterine cavity

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary
Time Frame: 2 years
To define "angular pregnancy" using ultrasound based criteria.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary
Time Frame: 2 years
To prospectively validate the ultrasound measurements that could be used to define implantation site in early pregnancy
2 years
Secondary
Time Frame: 2 years
To correlate these measurements with pregnancy outcome (miscarriage vs no miscarriage)
2 years

Collaborators and Investigators

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

Sponsor

King's College Hospital NHS Trust

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 1, 2017

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 221321

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is available for reasonable requests including study protocol and anonymised data.

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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