Angular Pregnancy - Ultrasound Definition and Correlation With Clinical Outcomes

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06262373

Enrollment

236

Registered

2024-02-16

Start date

2017-10-01

Completion date

2019-10-01

Last updated

2024-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Miscarriage in First Trimester

Brief summary

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.

Interventions

DIAGNOSTIC_TESTUltrasound

Ultrasound based observational study

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 50 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Primary	2 years	To define angular pregnancy using ultrasound based criteria.

Secondary

Measure	Time frame	Description
Secondary	2 years	To prospectively validate the ultrasound measurements that could be used to define implantation site in early pregnancy

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026