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

NCT06986616 | Completed

• 1 other identifier: KCH19-005
• Study Type: observational
• Target: 436
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibroid; Miscarriage in First Trimester; Miscarriage in Second Trimester

Keywords

fibroid; miscarriage

Outcome Measures

Primary Outcomes (1)

• Miscarriage prior to 24 weeks

  Miscarriage prior to 24 weeks - or delivery prior to 24 weeks

  From enrollment to the end of data collection (data would be collected from 24 weeks)

Secondary Outcomes (3)

• Risk of miscarriage based on fibroid characteristics

  From enrollment until data colelction (from 24 weeks)

• Risk of miscarriage according to trimester

  From enrollment to end of data collection (from 24 weeks)

• Presence of symptoms of pain or bleeding and association with fibroids and trimester

  From enrollment to end of data collection (from 24 weeks)

Other Outcomes (1)

• Uterine volume and value as a surrogate marker for fibroid mapping

  From enrollment to end of data collection (from 24 weeks onwards).

Study Arms (2)

Cases - fibroids

Women with fibroids

Controls - no fibroids

Women without fibroids

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women attending the early pregnancy unit in our London hospital will be the target population.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

Early Pregnancy and Gynaecology Assessment Unit, King's College Hospital NHS Foundation Trust

London, London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Leiomyoma; Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: January 9, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)