Validating a non-invasive pain relief device for pregnancy
Pregnant women in their third trimester experienced better sleep and less pain using a specialised maternity airbed tested in a Mobius-run pilot trial. The study validated safety, comfort, and efficacy—proving a non-invasive way to ease late-pregnancy discomfort.
Pregnancy is a magical time but also one that can be challenging for thoseexpecting. Studies have shown that 70% - 80% of expecting mothers experience lower-back and pelvicgirdle pain in the third trimester of their pregnancy. At a time when rest isparamount, it is most elusive. The Belly Bed is a unique maternityairbed designed to address this problem.
The airbed utilizes a specialized mattress system, with a uniquecontouring design and adjustable sections, to accommodate a growing belly andreduce pressure on the back, hips, and pelvis. This system is a non-invasivesolution and required clinical evidence to support the claims that it providedpain relief for pregnant women in their third trimester.
MobiusMedical partnered with The Belly Bed to run a pilot trial to prove the efficacyof their claims. Even with a non-invasive device, clinical trials for pregnantwomen are significantly harder and complex to deliver. There are two patients(the mother and the foetus), there are complex regulatory barriers to navigate,and recruitment is challenging. To navigate such a trial, The Belly Bedrequired a partner who had deep expertise in the field, could navigateregulatory requirements, and most importantly could provide a high-level ofsupervision and care for patients recruited to ensure their safety. As aboutique firm with 18+ years of experience in the field, Mobius was able todeliver on these requirements.
Mobiusconducted user trials with pregnant women and healthcare providers to measurepain relief of the back, safety, and durability. The results were positive,with reported improvements in sleep quality, reduced musculoskeletaldiscomfort, and higher satisfaction compared to traditional supports. This metthe primary endpoint of the study. However, beyond that, it provided a novel,non-invasive solution a viable pathway to improving maternal well-being andrecovery, with potential applications in broader therapeutic care settings.
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Key outcomes
- Successful pilot trial conducted with pregnant women in their third trimester
- Demonstrated improvements in sleep quality and musculoskeletal pain reduction
- Confirmed safety and comfort through healthcare provider evaluation
- Validated a non-invasive approach to maternal pain management
- Established pathway for broader therapeutic and commercial applications