Miscarriage in First TrimesterNCT06262373
Angular Pregnancy - Ultrasound Definition and Correlation With Clinical Outcomes
An observational study of Miscarriage in First Trimester, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Miscarriage in First Trimester
- What is being tested?
- Ultrasound
- How many people
- 236 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2017to 1 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Pregnant women who are attending for a scan in the early pregnancy unit, aged over 16 years.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are Early Pregnancies Implanted Close to the Tubal Ostia at Increased Risk of Miscarriage? A Prospective Observational Study
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
- Being tested
- Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Ultrasound based observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary
To define "angular pregnancy" using ultrasound based criteria.
Measured: 2 years
Secondary outcomes (2)
Secondary
To prospectively validate the ultrasound measurements that could be used to define implantation site in early pregnancy
Measured: 2 years
Secondary
To correlate these measurements with pregnancy outcome (miscarriage vs no miscarriage)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Oct 2017
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Miscarriage in First TrimesterStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262373
- Sponsor's protocol ID
- 221321
- Status last verified
- Feb 2024
- First submitted
- 25 Apr 2023
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available for reasonable requests including study protocol and anonymised data.
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Early Pregnancies Implanted Close to the Tubal Ostia at Increased Risk of Miscarriage? A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06262373
- Acronym / sponsor ID
- 221321
- Conditions
- Miscarriage in First Trimester
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Pregnant women who are attending for a scan in the early pregnancy unit, aged over 16 years.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundUltrasound based observational study | Diagnostic test | – |
Primary outcome
Primary
Time frame: 2 years
To define "angular pregnancy" using ultrasound based criteria.
2 secondary outcomes
Secondary
Time frame: 2 years
Secondary
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: No. Data is available for reasonable requests including study protocol and anonymised data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Miscarriage in First Trimester, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.