Fibroid, Miscarriage in First Trimester, Miscarriage in Second Trimester
Conditions
Keywords
fibroid, miscarriage
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.
Interventions
None listed
Sponsors
King's College Hospital NHS Trust
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Miscarriage prior to 24 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Risk of miscarriage based on fibroid characteristics | From enrollment until data colelction (from 24 weeks) | Risk of miscarriage based on volume, size and location of fibroids |
| Risk of miscarriage according to trimester | From enrollment to end of data collection (from 24 weeks) | Risk of miscarriage according to trimester |
| Presence of symptoms of pain or bleeding and association with fibroids and trimester | From enrollment to end of data collection (from 24 weeks) | Presence of symptoms of pain or bleeding and association with fibroids and trimester |
Other
| Measure | Time frame | Description |
|---|---|---|
| Uterine volume and value as a surrogate marker for fibroid mapping | From enrollment to end of data collection (from 24 weeks onwards). | Can uterine volume be used as a surrogate marker for fibroid mapping - and does this have an association with miscarriage |
Countries
United Kingdom
Outcome results
None listed