Clinical trial NCT06986616: Fibroids and the Risk of Miscarriage: a Prospective Observational Study in an Early Pregnancy Population
Official title: Fibroids and the Risk of Miscarriage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibroid
Miscarriage in First Trimester
Miscarriage in Second Trimester
Keywords: fibroid
miscarriage
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 436
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women attending the early pregnancy unit in our London hospital will be the target population.

Brief 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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Miscarriage prior to 24 weeks
timeFrame: From enrollment to the end of data collection (data would be collected from 24 weeks)
Secondary outcomes:
measure: Risk of miscarriage based on fibroid characteristics
timeFrame: From enrollment until data colelction (from 24 weeks)
measure: Risk of miscarriage according to trimester
timeFrame: From enrollment to end of data collection (from 24 weeks)
measure: Presence of symptoms of pain or bleeding and association with fibroids and trimester
timeFrame: From enrollment to end of data collection (from 24 weeks)
Other outcomes:
measure: Uterine volume and value as a surrogate marker for fibroid mapping
timeFrame: From enrollment to end of data collection (from 24 weeks onwards).
Locations:
city: London
country: United Kingdom
facility: Early Pregnancy and Gynaecology Assessment Unit, King's College Hospital NHS Foundation Trust
Study officials:
References: