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NCT06986616: FiRM
Fibroids and the Risk of Miscarriage: a Prospective Observational Study in an Early Pregnancy Population
trial in Fibroid in 436 participants. Completed in 1 October 2020.
1 October 2020
Quick facts
| Lead sponsor | King's College Hospital NHS Trust |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 436 |
| Start date | 9 January 2019 |
| Primary completion | 1 October 2020 |
| Estimated completion | 1 October 2020 |
| Sites | 1 location across United Kingdom |
Conditions studied
- Fibroid — all drugs for Fibroid →
- Miscarriage in First Trimester — all drugs for Miscarriage in First Trimester →
- Miscarriage in Second Trimester — all drugs for Miscarriage in Second Trimester →
Sponsor
King's College Hospital NHS Trust
Who can join
16 and older, female only, with Fibroid or Miscarriage in First Trimester. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06986616
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other recruiting trials for Fibroid
Currently open trials in the same condition.
- NCT06143631 — Prescription of Letrozole for Uterine Myoma · Phase 4 · recruiting
- NCT06135870 — Role of Senescent Cells in Uterine Fibroid Pathogenesis (SOUL Study) · recruiting
Other King's College Hospital NHS Trust trials
Trials by the same sponsor.
- NCT07384884 — Surgery and Laser Interstitial Thermal Therapy for Bilateral Glioblastomas · NA · not yet recruiting
- NCT07379723 — Brief Intervention for FCD: A Feasibility Study · NA · recruiting
- NCT07062731 — Pelvic Floor Exercises for Suboptimal Anorectal Manometry · recruiting
- NCT06766162 — Virtual Reality to Improve Patient Experience During Endoscopic Mucosal and Submucosal Resection · NA · completed
- NCT06918756 — Development of a Cough Control Questionnaire (CCQ) · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06986616 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by King's College Hospital NHS Trust
- Last refreshed: 23 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06986616.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing