Angular Pregnancy - Ultrasound Definition and Correlation With Clinical Outcomes

NCT ID: NCT06262373

Last Updated: 2024-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

236 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Miscarriage in First Trimester

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Ultrasound

Ultrasound based observational study

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

* 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
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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King's College Hospital NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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King's College Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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221321

Identifier Type: -

Identifier Source: org_study_id

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