Fibroids and the risk of miscarriage
Research type
Research Study
Full title
Fibroids and the risk of miscarriage
IRAS ID
247418
Contact name
Jackie Ross
Contact email
Sponsor organisation
King's College Hospital NHS Foundation Trust - R&I Manager
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Fibroids are thought to lead to an increased risk of miscarriage where they are partly in the womb cavity (sharing the same space as the pregnancy). This opinion has come from retrospective studies which can be biased. One recent study which followed up women during pregnancy (prospectively) showed that fibroids did not lead to miscarriage risk. This study was conducted in the United States and differs to the population of women we see in London.
The aim of this study is to follow up women in our population in the first and second trimester to assess if fibroids lead to an increased risk of miscarriage. We will be collecting data via a questionnaire detailing other factors which may have an impact on overall health and on the risk of miscarriage. By collecting data regarding other factors, we hope to only assess the true effect of fibroids. We will also be looking at location, number and size of the fibroids and their effects.
All women attending the unit with a normal pregnancy inside the womb and less than 10 weeks either from last menstrual period or by the appearances on scan (ultrasound) will be invited to take part. All women will have an internal scan as part of routine care where the pregnancy will be assessed including the womb, fibroids and ovaries. Following the scan, eligible women choosing to take part in the study will be asked to provide written consent and complete a questionnaire. Researchers will access pregnancy records for data collection. Women will also receive a follow up call at 24 weeks. All study data will remain confidential and anonymised. After analysing the data, we will be able to say whether fibroids lead to an increased risk of miscarriage – this information will be useful in counselling women affected by fibroids.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0724
Date of REC Opinion
16 Oct 2018
REC opinion
Favourable Opinion