Angular Pregnancy - Ultrasound Definition and Correlation With Clinical Outcomes

Completed

• Conditions: Miscarriage in First Trimester

• Registration Number: NCT06262373
• Lead Sponsor: King's College Hospital NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Primary Completion: 2019-10-01
• Study Completion: 2019-10-01
• Study First Submitted: 2023-04-25
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-06
• Last Update Submitted: 2024-02-06
• Study First Posted: 2024-02-16
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 236

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary	2 years	To define "angular pregnancy" using ultrasound based criteria.

Secondary Outcome Measures

Name	Time	Method
Secondary	2 years	To correlate these measurements with pregnancy outcome (miscarriage vs no miscarriage)

Trial Locations

Locations (1)

King's College Hospital; 🇬🇧 London, United Kingdom