The results of a national medical research trial could bring benefits to women in north Cumbria with bleeding in pregnancy who have experienced previous miscarriages.
North Cumbria University Hospitals NHS Trust was one of 48 centres in the UK to take part in in the ‘PRISM’ trial which studied over 4,000 pregnant women. 31 of those women attended the Cumberland Infirmary in Carlisle where Dr Laura Hipple, associate specialist in obstetrics & gynaecology was leading the trial alongside Rachel Hardy, research midwife.
The findings of the trial has shown that giving the hormone progesterone can prevent miscarriages in those who have bleeding in early pregnancy and who have had previous miscarriages. Progesterone is a natural hormone that helps to grow the lining of the womb and supports the immune system.
Miscarriage affects one in five women, and vaginal bleeding in early pregnancy is linked to an increased risk of it happening.
The PRISM trial was a randomised controlled trial with half of the 4153 women given progesterone and half given placebo (dummy) tablets. The results showed that for women experiencing bleeding in early pregnancy:
- With no previous miscarriages there was no benefit found
- With one or more previous miscarriages there was a 5% increase in live births
- With three or more previous miscarriages there was a 15% increase in live births
Dr Laura Hipple explains: “This is the first time we have had clear evidence about this drug and the women it may benefit. While the treatment is not helpful for all women with bleeding in pregnancy we will be changing our clinical practice regarding those with bleeding and a history of repeated losses in future.
“We are extremely proud of and grateful to the women who took part in this trial. When they agreed to take part they didn’t know if it would be of benefit to them but they knew they could be helping others in the future.”
Rachel Hardy, added: “Clinical research is very much about teamwork between the staff involved and the people who agree to take part. By taking part in research here in Cumbria it enables us to stay up to date with clinical best practice and to make key breakthroughs such as in the PRISM trial. We could not have achieved this without commitment from our colleagues and from the women who agreed to take part.”
Although the results are encouraging, Dr Hipple would like to emphasise the importance of a healthy lifestyle in preventing miscarriages: “All women who are planning a pregnancy can reduce their risk of miscarriage by stopping smoking and ensuring they are a normal weight before conceiving.”
The PRISM trial was funded by the National Institute for Health Research (NIHR) and coordinated by the Birmingham Clinical Trials Unit and the Tommy’s National Centre for Miscarriage Research
For more information about planning a pregnancy, visit https://www.tommys.org/pregnancy-information/planning-pregnancy
Light vaginal bleeding is relatively common during the first trimester (first 3 months) of pregnancy and doesn’t necessarily mean you’re having a miscarriage. If you have vaginal bleeding in early pregnancy, contact your GP or midwife as soon as possible. If the bleeding is extremely heavy, or associated with persistent or severe pain, or you feel faint or unwell please attend your nearest emergency department. For more information about miscarriage see : www.miscarriageassociation.org.uk