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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06262373
Other study ID # 221321
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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