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

Completed

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

• Registration Number: NCT06986616
• Lead Sponsor: King's College Hospital NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-09
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 436

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Early Pregnancy and Gynaecology Assessment Unit, King's College Hospital NHS Foundation Trust; 🇬🇧 London, United Kingdom