Clinical trial · Observational
Fibroids and the Risk of Miscarriage: a Prospective Observational Study in an Early Pregnancy Population
Fibroids and the Risk of Miscarriage
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroid | Leiomyoma | ALIAS | 0.90 |
| Miscarriage in First Trimester | — | UNRESOLVED | — |
| Miscarriage in Second Trimester | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cases - fibroids
- description
- Women with fibroids
- label
- Controls - no fibroids
- description
- Women without fibroids
Primary outcomes (1)
- measure
- Miscarriage prior to 24 weeks
- timeFrame
- From enrollment to the end of data collection (data would be collected from 24 weeks)
- description
- Miscarriage prior to 24 weeks - or delivery prior to 24 weeks
Secondary outcomes (3)
- measure
- Risk of miscarriage based on fibroid characteristics
- timeFrame
- From enrollment until data colelction (from 24 weeks)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Embryonic demise * Under 16 * Unable to understand - interpreting services will be used such as language line if required.
References
Publications (0)
Data not yet available