Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT06986616
Status:
COMPLETED
Last Update Posted:
2025-05-23
First Post:
2025-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fibroids and the Risk of Miscarriage: a Prospective Observational Study in an Early Pregnancy Population
Sponsor:
King's College Hospital NHS Trust
Organization:
Study Overview
Official Title:
Fibroids and the Risk of Miscarriage
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FiRM
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: