Case study: Midwife who took part in miscarriage drug trial urges others to say yes

The National Institute for Health and Care Research (NIHR)-funded and supported PRISM trial recruited more than 4,000 women across the UK, at hospital trusts including Somerset NHS Foundation Trust, University Hospitals Plymouth NHS Trust, Northern Devon Healthcare NHS Trust and the Royal Devon & Exeter NHS Foundation Trust (Northern Devon and the Royal Devon & Exeter have since merged, creating the Royal Devon University Healthcare NHS Foundation Trust).

One of those who volunteered to take part was Hannah Twinney, a Labour Ward Sister (a senior midwife position) at Somerset NHS Foundation Trust. As a trained expert Hannah was well aware of the significance of the bleeding she experienced one morning, six weeks into her first pregnancy in 2016.

“It was early on in the pregnancy when I woke up and had quite a lot of bleeding. As a midwife, well you know exactly what’s going on,” Hannah recalls. “We went to the Early Pregnancy Assessment Clinic at Musgrove Park Hospital in Taunton, and after telling the staff about the bleeding, they didn't look very hopeful at all.

“But they did a scan and found a yolk sac, which was a promising sign. So they said they couldn’t see any reason for the bleeding, and we’d just have to watch and wait. This was obviously really nerve-wracking – I was quite young and it was my first pregnancy.”

Hannah was invited to take part in PRISM (Progesterone in Spontaneous Miscarriage) by the team at Musgrove Park, in Taunton. The study, led by the University of Birmingham, was set up to confirm the perceived benefits of the progesterone hormone in women with early pregnancy bleeding, which can be a sign that a miscarriage may occur.

Although the cause isn’t always clear, some miscarriages may be linked to a drop in progesterone as the pregnancy develops. Earlier small studies had suggested that giving progesterone to women with early pregnancy bleeding may reduce their risk of miscarriage, but the evidence was uncertain.

The study eventually showed that progesterone treatment increased the likelihood of a baby being delivered in women with the dual risk factors of early pregnancy bleeding and a history of previous pregnancy loss. The study also showed that the higher the number of previous miscarriages a woman has suffered, the greater the benefit of progesterone treatment.

“They told me a little bit about it and I said yes straight away,” Hannah continued. “I knew how important the research was. And I thought even if I was going through a miscarriage, it would be great to be part of something happening on our labour ward as part of the care for our women.

“The rest is history: I took the pessaries until I was 16-weeks pregnant, went back for the scan when I was seven-and-a-half weeks and they saw a heartbeat, which was amazing, just incredible to see. And by that time the bleeding had stopped as well.”

Hannah gave birth to her son Hugo in spring 2017. Later, she discovered that she had been in the group that had received progesterone, rather than a placebo as part of PRISM. She said: “Finding out that I did have the progesterone felt really important to me.

“It felt almost like he might not have been here if I hadn't had it. It will be really special to me forever, and it will be something that I tell him when he gets older. We even saved some of the boxes and the patient information leaflets in his memory box because that's what you do when you have your first baby, you save everything.”

And would Hannah recommend others take part in a clinical trial if offered the chance?

“Yes, do it! The main thing for me was, I knew it was going to be safe for me and I knew it was going to be safe for my baby. And working in maternity, probably the biggest factor was that I knew it was going to help people in the future, people I’d be working with.”

Read more about the change in NICE guidelines following the PRISM study here.

If you are interested in volunteering for health and care research, visit https://bepartofresearch.nihr.ac.uk/.