Angular Pregnancy - Ultrasound Definition and Correlation With Clinical Outcomes

NCT06262373 | Completed

• 1 other identifier: 221321
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

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.

Conditions

Miscarriage in First Trimester

Outcome Measures

Primary Outcomes (1)

• Primary

  To define "angular pregnancy" using ultrasound based criteria.

  2 years

Secondary Outcomes (2)

• Secondary

  2 years

• Secondary

  2 years

Interventions

Ultrasound DIAGNOSTIC_TEST

Ultrasound based observational study

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Design

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

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: February 16, 2024
• Study Start: October 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)