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Completed

NCT Number: NCT06986616

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

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.

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Key information

Age range

16 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

London, SE5 9RS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Miscarriage prior to 24 weeks

    Time frame: 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 outcomes

  1. Risk of miscarriage based on fibroid characteristics

    Time frame: From enrollment until data colelction (from 24 weeks)

    Risk of miscarriage based on volume, size and location of fibroids

  2. Risk of miscarriage according to trimester

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

    Risk of miscarriage according to trimester

  3. Presence of symptoms of pain or bleeding and association with fibroids and trimester

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

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

Other outcomes

  1. Uterine volume and value as a surrogate marker for fibroid mapping

    Time frame: 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

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Registry information

Official study title

Fibroids and the Risk of Miscarriage

Acronym: FiRM

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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