Progesterone treatment for threatened miscarriage increases live birth rate
Results of the PRISM study published in the New England Journal of Medicine in May 2019
Funded by the National Institute for Health Research
Mrs Caroline Overton is primary investigator at St Michaels University hospitals Bristol Early Pregnancy Assessment Clinic.
PRISM is a double-blind, placebo-controlled trial to test the hypothesis that in women presenting with bleeding in the first 12 weeks of pregnancy, progesterone 400mg vaginal capsules twice daily started as soon as possible after a scan has confirmed a visible intra-uterine pregnancy and continued to 16 weeks of completed pregnancy, compared with identical placebo increases live births beyond 34 completed weeks by at least 5%.
A total of 4153 women were recruited at 48 hospitals in the UK, and randomly assigned to receive progesterone (2079 women) or placebo (2074 women). Data was available for 4038 of 4153 women.
The incidence of live births after 34 weeks gestation was 75% (1513/2025 women) in the progesterone group and 72% (1459/2013 women) in the placebo group. The 3% difference in live birth was not statistically significant, meaning that the difference could be due to chance. The incidence of adverse events did not differ significantly between the groups.
However, when the results were split by number of previous miscarriages, the analysis showed that in women with
- No previous miscarriages the live birth rate was 74% (824/1111) in the progesterone group and 75% (840/1127) in the placebo group i.e. no benefit
- 1-2 previous miscarriages the live birth rate was 76% (591/777) in the progesterone group and 72% (534/735) in the placebo group i.e. some benefit
- 3 or more previous miscarriages the live birth rate was 72% (98/137) in the progesterone group and 57% (85/148) in the placebo group i.e. substantial benefit
The results of the study suggests that women with bleeding in early pregnancy with a history of previous miscarriage could benefit from progesterone treatment has huge implications. This treatment could save thousands of babies who may otherwise have been lost to miscarriage.
A study evaluating the economic implications of the PRISM trial published in the British Journal of Obstetrics & Gynaecology concludes that progesterone is cost-effective, costing on average £204 per pregnancy.
Elagolix - a potential new treatment for endometriosis
Results published in the New England Journal of Medicine
Endometriosis research Elaris EM-I and Em-II funded by AbbVie
ClinicalTrials.govnumbers NCT 01620528
ClinicalTrials.govnumbers NCT 01931670
(Elaris Endometriosis I & II)
Mrs Overton was primary investigator of the Elaris EM-I trial at University Hospitals Bristol NHS Foundation Trust.
Two double-blind, six-month trials were carried out to evaluate the effects of two doses of Elagolix 150 mg once daily (low-dose group) and 200 mg twice daily (higher-dose group) as compared with placebo in women with surgically diagnosed endometriosis and moderate to severe endometriosis-associated pain.. The two primary endpoints were the proportion of women who responded with respect to dysmenorrhoea (painful periods) and the proportion who had a clinical response with respect to non-menstrual pelvic pain (pain unrelated to periods) at three months.
A total of 872 women underwent randomisation and of these women, 653 (74.9%) and 632 (77.4%) respectively completed the treatment. At three months, a significantly greater proportion of women who received either Elagolix dose showed a significant clinical response than those women on placebo.
The percentage of women who had clinical response with respect to dysmenorrhoea was 46.4% in the lower dose Elagolix group and 75.8% in the higher dose Elagolix group compared with 19.6% in the placebo group.
The percentage of women who had a clinical response with respect to non-menstrual pelvic pain was 50.4% in the lower dose Elagolix group and 54.5% on the higher dose Elagolix group as compared to 36.5% in the placebo group.
The responses with respect to dysmenorrhoea and non-menstrual pelvic pain were sustained at six months. Women who received Elagolix had higher rates of hot flushes (mostly mild or moderate) higher levels of serum lipids and greater decreases from baseline in bone mineral density than those who received placebo. There were no adverse endometrial findings.
In women with endometriosis-associated pain, both higher and lower doses of Elagolix were effective in improving dysmenorrhoea (painful periods) and non-menstrual pelvic pain (pain unrelated to periods) during a six-month period. Both doses were associated with hypo-oestrogenic adverse effects mostly mild or moderate hot flushes.
Ultrasound scan course
Mrs Overton was on the faculty for the Certificate in Obstetrics and Gynaecology Ultrasound course in Dubai from 6 to 8 Feb 2020. The course used some of the world's most modern and state-of-the-art simulators.
Supporting International Women's Day
Mrs Overton supported International Women's Day at the Bristol City Hall on Saturday 2nd March 2019 by discussing Menopause: Medicine, Society, Work and Self.
She was part of an expert panel with Lauren Chiren, Beccy Golding, Isabel de Salis and Daisy Rajput exploring the impact of menopause on women's lives.
Thyroxine treatment for miscarriage trial published
Miscarriage research at St Michael's University Hospital Bristol early Assessment Clinic.
Mrs caroline Overton Primary Investigator
Funded by the national Institute for Health Research.
The results of the TABLET trial have been published in the New England Journal of Medicine in March 2019.
The TABLET trial was a double-blind, placebo-controlled trial to investigate whether levothyroxine treatment would increase live-birth rates among women who have normal thyroid function with thyroid peroxidase antibodies and a history of miscarriage or infertility. A total of 19,585 women from 49 hospitals in the United Kingdom underwent testing for thyroid peroxidase antibodies and thyroid function.
The results showed that the use of levothyroxine in euthyroid women with thyroid peroxidase antibodies did not result in a higher rate of live births than placebo. (Funded by the United Kingdom National Institute for Health Research; TABLET Current Controlled Trials number, ISRCTN15948785.)
Caroline talks to John Darvall about menopause on BBC Radio Bristol
Caroline talks to John Darvall on BBC Radio Bristol on Friday 12 May 2017 about the menopause transition.
Listen to a clip from the programme (90sec, MPEG4).
Fibroid management article in The Practitioner
Mrs Overton is co-author on the paper. Read the article: Tailor management to the patient with fibroids (pdf)
Caroline is top 100 researcher
Caroline was awarded top 100 researcher UK with a presentation at BMA House in London in February 2016.
Using HRT to manage the menopause article in The Practitioner
Mrs Overton is co-author. Read the article: Managing debilitating menopausal symptoms (pdf)
NICE Endometriosis guideline published September 2017
After competitive interviews, Caroline was appointed to the position of Chair of the NICE Guideline Committee on the diagnosis and management of Endometriosis. The NICE Endometriosis guideline was published in September 2017 following public and stakeholder consultation.
See the Recommendations on on the NICE website.
See the Full guideline on the NICE website
(TABLET) Thyroxine treatment for miscarriage trial
Mrs Caroline Overton is Primary Investigator for the TABLET trial at St Michael's University Hospitals Bristol Early Pregnancy Assessment Clinic.
The TABLET Trial is a large, double blind, placebo controlled trial that will test the hypothesis that in euthyroid women with thyroid peroxidase antibodies, levothyroxine (50mcg, oral, once daily), started before pregnancy and continued to the end of pregnancy, increases live births beyond 34 completed weeks of gestation by at least 10% compared with placebo.
4 signs of endometriosis women should never ignore
Many women put up with these symptoms for years, not realising the damage they are doing to their health and fertility. Here's your need-to-know guide on the signs of endometriosis. Endometriosis explained video and guide by Caroline.
Suffering in silence with endometriosis - OK Magazine
Caroline gives expert advice on suffering in silence with Endometriosis published in OK Magazine for Endometriosis Awareness week 3 March 2015.
Read the article in OK (pdf)
Recovering after keyhole surgery for endometriosis
Caroline advises Mail Online readers about what to do to ensure a good recovery after surgery for endometriosis. Read a copy of the February 2015 article (pdf).
NICE evidence on the diagnosis and management of miscarriage and ectopic pregnancy
In December 2014, Caroline was a member of the Guideline Development Group that provided advice on the diagnosis and management of ectopic pregnancy and miscarriage in early pregnancy.
New NICE guidelines published on ectopic pregnacy: diagnosis and initial management (update). Guidelines
NICE guidance on miscarriage and ectopic pregnancy
Caroline was a member of the NICE guideline development committee that developed new guidance on miscarriage and ectopic pregnancy. In this clip from national BBC Breakfast she talks about the new guidelines. BBC miscarriage article on BBC Breakfast.
Bladder Endometriosis in Endolink magazine
Endolink - Endometriosis UK's magazine - features an article by Caroline on Bladder Endometriosis - a rare but treatable condition. Endolink Bladder Endometriosis article (pdf).
St Michael's is fully accredited by the British Society for Gynaecological Endoscopy as an Endometriosis Centre providing excellence in the treatment of endometriosis (accredited centres list).
This is great news for St Michael's and confirms its status as a leading centre.
Caroline contributes to Cosmopolitan article about endometriosis
The article describes what endometriosis means to a sufferer, Frances and Caroline explain the condition and comment on the difficulty GPs have in making the diagnosis. Cosmopolitan endometriosis article, April 2012 (pdf)
Secret guide to Women's Health to be repeated
Sky Television's 'The secret guide to Women's Health' series is to be repeated on the Sky living channel. The ten-part series aims to raise awareness of women's health issues - many of which are often considered taboo. Each programme featured two women who came into the studio and shared their experience of a particular condition. Caroline was nominated by Endometriosis UK as an expert on Endometriosis and involved in the studio discussion with host Coleen Nolan and resident GP, Dr Rosemary Leonard.
Caroline is NHS Choices expert
The new NHS Choices video on endometriosis features Caroline as the endometriosis expert. The video outlines the symptoms and treatment options, who is affected by it and how to cope with the pain. NHS Choices endometrosis video.