A new device promises to provide midwives with a “third hand”, substantially reducing perineal tears, but could it really work?
“Simply surviving pregnancy and childbirth can never be the marker of successful maternal healthcare”, the World Health Organisation concluded after a damning report revealed that 287 000 women died in 2020 during and following pregnancy.
While maternal mortality rates are down sharply from where they were 20 years ago, research by United Nations shows that progress toward reaching the UN’s sustainable development goal of reducing maternal mortality has stalled.
According to the United Nations Population Fund (UNFPA), every two minutes a woman dies because of complications due to child birth or pregnancy.
But maternal mortality is not the only problem – for every woman who dies, there are about 20 to 30 women who experience injury, infection, or other birth or pregnancy related complication.
“Maternal mortality is only the tip of the iceberg when it comes to maternal health,” says Ditte Marie Fog Ibsen, co-founder and CEO of oasicare, a medtech start-up based in Copenhagen.
“Maternal morbidity is the hidden base, predominantly featured by perineal ruptures.”
Perineal ruptures are extremely common and expected complications of vaginal birth. In the UK, about 85 per cent of women sustain some degree of perineal trauma during childbirth.
Multiple studies have found that some women who experience severe perineal lacerations suffer long term psychological trauma and social isolation. However, the stigma around the topic means that many feel too embarrassed to seek help.
“Postnatal care is mainly focused on women with higher grades of perineal ruptures, downplaying the impact of lower grade ruptures on woman’s quality of life,” says Fog Ibsen.
“Short, medium and long-term complications are fairly common but rarely acknowledged or prioritised in the global health landscape.”
‘Women’s tears are not properly assessed’
Fog Ibsen and her friend, Julia Sand, were working as industrial designers creating solutions for midwifes when they realised the scale of the problem.
“We were trying to help midwifes manage their work-related musculoskeletal symptoms when we came across a even bigger problem: perineal ruptures.
“At the time, we didn’t know much about it, but we knew we had to do something about it.”
The duo began researching the issue and came up with a single-use medical device designed to protect the perineum and reduce uterine ruptures.
The product, which is currently being tested in several hospitals in Denmark, is adhesive and acts like a protective layer that prevents ruptures during childbirth.
“We are essentially trying to replicate the skin so we can prevent ruptures, which tend to happen when the vagina and perineum stretch during birth,” explains Fog Ibsen.
“We’ve made it very simple so that it can be easily applied and easily taken off.”
The interesting part, she says, is that women don’t actually notice it.
“That’s a quite good thing because there’s a lot of attention on the birth. The midwifes were a bit worried initially about the adhesive and whether it could last and stick to different types of skin, but so far it’s been great.”
The midwifes have played a crucial role in the product development process, helping the oasicare team identify issues early on and improve the device.
“We relied on their knowledge to get the balance right so that in the future we can give the product to people who doesn’t have the same level of experience, but can still use it to prevent ruptures.
“The product is very easy to cut in, for example, so that midwives can adjust it easily.”
Currently, the team is not allowed to disclose any details about the efficacy of the product but a study, which is expected to conclude later this year, will establish how much the device could reduce ruptures.
“If all the studies go well and we get good data from the hospitals we work with we could see the product on the market in 2025,” says Fog Ibsen.
Her goal, however, is to launch the device outside Denmark where, she says, women desperately need it.
“In Denmark, I think, the midwives are doing a great job, but in other parts of the world the situation is very different. Women’s tears are not properly assessed, which means that despite having suffered serious tears they are being told that everything’s just fine.
“Our goal is to make the product available in countries like India, where a lot of women would benefit from it. It’s a simple device, but it can have such a big impact.”
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The post Could an adhesive device be the answer to perineal tears? This start-up thinks so appeared first on FemTech World.
The post Could an adhesive device be the answer to perineal tears? This start-up thinks so appeared first on FemTech World.