FibroidFiRMNCT06986616
Fibroids and the Risk of Miscarriage: a Prospective Observational Study in an Early Pregnancy Population
An observational study of Fibroid and Miscarriage in First Trimester, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
The aim of this observational study is to whether fibroids increase the risk of miscarriage in women in our early pregnancy population. We will be collecting lots of data detailing other factors, which may have an impact on overall health and on the risk of miscarriage (this includes age, weight, use of vitamins or… Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibroid, Miscarriage in First Trimester, Miscarriage in Second Trimester
- How many people
- 436 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jan 2019to 1 Oct 2020
- 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 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Women attending the early pregnancy unit in our London hospital will be the target population.
Who may be able to join
- All women presenting at less than 10 weeks gestation either by last menstrual period or by transvaginal scan findings with an early intrauterine or ongoing pregnancy on scan
Who cannot join
- Women declining participation and follow up
- Women wishing to pursue termination of pregnancy
- Women who refuse transvaginal scan
- Multiple pregnancy
- Ectopic pregnancy
- Pregnancy of unknown location
Show all 9Show fewer
- Embryonic demise
- Under 16
- Unable to understand - interpreting services will be used such as language line if required.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Early Pregnancy and Gynaecology Assessment Unit, King's College Hospital NHS Foundation Trust
London, London, SE5 9RS
About this study
Official title: Fibroids and the Risk of Miscarriage
The aim of this observational study is to whether fibroids increase the risk of miscarriage in women in our early pregnancy population.
We will be collecting lots of data detailing other factors, which may have an impact on overall health and on the risk of miscarriage (this includes age, weight, use of vitamins or progesterone supplements, postcode which is linked to national deprivation scoring status and employment status).
Read more
By collecting all this data, we hope to remove the effect of other factors and purely assess the effect that the fibroids have on the outcome in early pregnancy.
We will also be looking closely at whether the location, number or size of the fibroids can affect the pregnancy too and following up women at 24 weeks via phone. We will also look at other secondary outcomes such whether women with fibroids experience symptoms of pain or bleeding in the first or second trimester more so than their control counterparts. We will also look at the value of uterine volume as a surrogate marker of fibroid mapping.
Once all the data has been analysed, we will be able to assess whether fibroids lead to an increased risk of miscarriage. We hope that this information will be useful in counselling women affected by fibroids in the pregnancy.
- Keywords
- fibroid, miscarriage
- Medical subject headings
- Leiomyoma, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases - fibroids | Women with fibroids | |
| Controls - no fibroids | Women without fibroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Miscarriage prior to 24 weeks
Miscarriage prior to 24 weeks - or delivery prior to 24 weeks
Measured: From enrollment to the end of data collection (data would be collected from 24 weeks)
Secondary outcomes (3)
Risk of miscarriage based on fibroid characteristics
Risk of miscarriage based on volume, size and location of fibroids
Measured: From enrollment until data colelction (from 24 weeks)
Risk of miscarriage according to trimester
Risk of miscarriage according to trimester
Measured: From enrollment to end of data collection (from 24 weeks)
Presence of symptoms of pain or bleeding and association with fibroids and trimester
Presence of symptoms of pain or bleeding and association with fibroids and trimester
Measured: From enrollment to end of data collection (from 24 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start9 Jan 2019
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibroidStudies 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
- 436 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
- NCT06986616
- Sponsor's protocol ID
- KCH19-005
- Acronym
- FiRM
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 23 May 2025
- 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 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibroids and the Risk of Miscarriage
- ClinicalTrials.gov ID
- NCT06986616
- Acronym / sponsor ID
- FiRM / KCH19-005
- Keywords
- fibroid, miscarriage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 436 participants (actual)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 23 May 2025 (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 observational study is to whether fibroids increase the risk of miscarriage in women in our early pregnancy population.
We will be collecting lots of data detailing other factors, which may have an impact on overall health and on the risk of miscarriage (this includes age, weight, use of vitamins or progesterone supplements, postcode which is linked to national deprivation scoring status and employment status).
By collecting all this data, we hope to remove the effect of other factors and purely assess the effect that the fibroids have on the outcome in early pregnancy.
We will also be looking closely at whether the location, number or size of the fibroids can affect the pregnancy too and following up women at 24 weeks via phone. We will also look at other secondary outcomes such whether women with fibroids experience symptoms of pain or bleeding in the first or second trimester more so than their control counterparts. We will also look at the value of uterine volume as a surrogate marker of fibroid mapping.
Once all the data has been analysed, we will be able to assess whether fibroids lead to an increased risk of miscarriage. We hope that this information will be useful in counselling women affected by fibroids in the pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases - fibroids | – | –Women with fibroids |
| Controls - no fibroids | – | –Women without fibroids |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women attending the early pregnancy unit in our London hospital will be the target population.
Key inclusion criteria (1 listed)
- All women presenting at less than 10 weeks gestation either by last menstrual period or by transvaginal scan findings with an early intrauterine or ongoing pregnancy on scan
Key exclusion criteria (9 listed)
- Women declining participation and follow up
- Women wishing to pursue termination of pregnancy
- Women who refuse transvaginal scan
- Multiple pregnancy
- Ectopic pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Miscarriage prior to 24 weeks
Time frame: From enrollment to the end of data collection (data would be collected from 24 weeks)
Miscarriage prior to 24 weeks - or delivery prior to 24 weeks
3 secondary outcomes
Risk of miscarriage based on fibroid characteristics
Time frame: From enrollment until data colelction (from 24 weeks)
Risk of miscarriage according to trimester
Time frame: From enrollment to end of data collection (from 24 weeks)
Presence of symptoms of pain or bleeding and association with fibroids and trimester
Time frame: From enrollment to end of data collection (from 24 weeks)
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 23 May 2025.
- 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 Fibroid and 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 1 inclusion and 9 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 23 May 2025. 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?
Miscarriage prior to 24 weeks (time frame: From enrollment to the end of data collection (data would be collected from 24 weeks)). 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 23 May 2025.