A medical harness designed by a North Wales businessman to help pregnant women combat acute pelvic pain has won a top industry innovation award.

The revolutionary harness is for women suffering intense pelvic girdle pain (PGP), also called symphysis pubic dysfunction.

Dafydd Roberts has been working with medics from Betsi Cadwaladr University Health Board (BCUHB) since designing the special support girdle to help his wife Ruth during her fourth pregnancy.

It is made by the family’s clothing and manufacturing business Brodwaith, based in Anglesey and Conwy, under the company name of HGR Ltd.

The harness is presently undergoing clinical trials by pregnant women across all of BCUHB’s hospital sites under a team of physiotherapists and health specialists led by Wrexham Maelor consultant obstetrician Dr Kalpana Upadhyay, an honorary lecturer at the University of Bangor.

HGR Ltd, which recently launched the product online, is now celebrating after scooping the prestigious Judges Award in the MediWales Research & Innovation Award ceremony.

The annual event, held at the National Museum of Wales in Cardiff and supported by Health and Care Research Wales, celebrates the achievements of the Welsh life science community.

Dafydd said: “It’s quite an honour to receive the award. We really didn’t expect to win as it’s a relatively simple idea but a lot of hard work has been put in by so many health professionals and this success is testament to everyone’s ongoing commitment.

“Up to now, we’ve opted for a soft launch really just to see how people respond to it. We’ve sold some online and we’ve had very positive feedback.

“Things are now moving pretty quickly. The trials are ongoing at the moment across all sites at the BCUHB. We’re getting quite a bit of interest without really pushing the product. Once we know the outcome of the trial we will get a much better idea.”

Dafydd, 40, who lives with Ruth and their children in Pentrefoelas, was inspired to design the special support girdle following his wife’s agony during pregnancy.

Ruth was unable to walk and was forced to use a wheelchair to get around because of the intense pelvic girdle pain she suffered while expecting her fourth child.

The condition is caused by an excess of pregnancy hormones that are designed to soften the pelvic muscles and ligaments to help with childbirth – but having too much of the hormones too soon can leave the sufferer in agony.

It affects one-in-five pregnant women and, in severe cases like Ruth’s, leaves the sufferer unable to walk through pain, with some experiencing lasting effects after the birth.

Ruth had previously experienced PGP towards the end of her third pregnancy although she had no problems with her first two children. The pain began just over 16 weeks into her pregnancy, when she was carrying her fourth child Harri.

Dafydd, with the help of Ruth, developed a harness that supported the weight of the bump, and held the pelvic bones in a comfortable position, which offered her immediate relief. He continued to improve on the design and eventually located the ideal material for the girdle from a supplier in America.

Wrexham Maelor Hospital consultant obstetrician Mrs Kalpana Upadhyay, a specialist in high-risk pregnancies, recognised the potential in the new harness from the outset.

She gathered a team of researchers, physiotherapists, midwives, industry managers from Health & Care Research Wales and experts from the clinical trials team NWORTH at the University of Bangor to investigate whether the device was better than current treatment available for PGP.

For this purpose, a randomised clinical trial was designed and recruitment of eligible participants commenced in 2016. The trial is expected to end by March 2017 after which the results will be revealed in an international medical conference in May 2017.

Dafydd and Ruth hope their product will then be accessible to thousands of women suffering the debilitating condition.

“This project has involved a lot of time and money to develop and there’s no getting away from that but unless you put it in you’re not going to be able to move on,” said Dafydd.

“We’re very confident with the product. The result of the trials will determine its wider potential but the response we’ve had from private customers has been very reassuring and positive.”

Dr Upadhyay added: “We feel very proud and happy to receive the award.

’The Judges’ choice award was given for ‘capturing the ethos of research and innovation and reflecting a true partnership between the NHS and industry.’

“This research started from the patient’s perspective. It stemmed from one woman’s difficulties during pregnancy and evolved into a major research project in which we built up a whole team of researchers and experts.

“It has taken a long time to progress as  the whole process usually takes between one to two years, but there has been strong team work throughout and now that we’ve almost completed the recruitment phase we should be able to disseminate the results very soon.”

Jan Fereday Smith, BCUHB Professional Lead for Physiotherapy said: “This has been a great opportunity for physiotherapists to get involved with a clinical trial and learn about the processes and scrutiny required, especially where there is such an exciting collaborative approach with industry.

“It’s great to help put the ‘University’ status into BCUHB.”

The company HGR is named after the couple’s son, explained Dafydd.

He  said: “Kalpana suggested the name Gravidarum and explained that it was the Latin for pregnancy – by putting Harness with the Gravidarum and, given that our son is called Harri Gwilym, it seemed like fate and we set up a new company called HGR Ltd, with the R being Roberts.”

More details about the pelvic girdle at www.maternity-belt.co.uk