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Completed

NCT Number: NCT06262373

Angular Pregnancy - Ultrasound Definition and Correlation With Clinical Outcomes

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.

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Key information

Conditions

Miscarriage in First Trimester

Age range

16 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

King's College Hospital

London, SE5 9RS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Diagnostic Test

Ultrasound based observational study

Primary outcomes

  1. Primary

    Time frame: 2 years

    To define "angular pregnancy" using ultrasound based criteria.

Secondary outcomes

  1. Secondary

    Time frame: 2 years

    To prospectively validate the ultrasound measurements that could be used to define implantation site in early pregnancy

  2. Secondary

    Time frame: 2 years

    To correlate these measurements with pregnancy outcome (miscarriage vs no miscarriage)

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 16, 2024
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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