Angular Pregnancy - Ultrasound Definition and Correlation With Clinical Outcomes

Miscarriage in First Trimester Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06262373
• Other study ID #: 221321
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: February 2024
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Miscarriage in First Trimester

Intervention

Diagnostic Test:
• Ultrasound
Ultrasound based observational study

Locations

Country	Name	City	State
United Kingdom	King's College Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary	To define "angular pregnancy" using ultrasound based criteria.	2 years
Secondary	Secondary	To prospectively validate the ultrasound measurements that could be used to define implantation site in early pregnancy	2 years
Secondary	Secondary	To correlate these measurements with pregnancy outcome (miscarriage vs no miscarriage)	2 years