Fibroids and the Risk of Miscarriage: a Prospective Observational Study in an Early Pregnancy Population (FiRM)

King's College Hospital NHS Trust

Status: Completed

Conditions: Miscarriage in First Trimester; Miscarriage in Second Trimester; Fibroid

Study type: Observational

Funder types: Other

Identifiers

NCT06986616

KCH19-005

Details and patient eligibility

About

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.

Enrollment: 436 patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

436 participants in 2 patient groups

Cases - fibroids

Description:

Women with fibroids

Controls - no fibroids

Description:

Women without fibroids