DVT and pregnancy

[charllejane]

Hi all,

I'm a third year Industrial Designer studying at Loughborough University and will be heading into my final year in October.

For my final major project I'd like to design a product in the 'FemTech' space - a product designed for women for periods of their life cycle such as puberty, pregnancy, post-pregnancy and menopause.

On a separate thread, someone previously mentioned that a product to monitor DVT (which is more likely during pregnancy) would be really helpful, and I'd like to gain more insight into this area.

I would love to hear your personal stories regarding DVT and what your ideals would be in terms of monitoring/tracking or so on that I could possibly develop a solution for.

Thanks in advance!

My only experience with it was needing to give myself a course of injections after each birth, and taking aspirin during pregnancy.

I'd never injected myself before so the first time I ended up with a fair few bruises. And I've still got the needles in the garage because no-one wants to take the sharps bin away - it's always someone else's responsibility. So yeah, somehow avoiding learning to self inject when dealing with a baby would be nice.

What do you mean by "monitor DVT"?

You can't really "monitor DVT". It's diagnosed in hospital via blood tests and scans. People can be on the look out for warning signs at home but not sure what exactly you are looking to design.

If you particularly wanted to focus on conditions during pregnancy I'd consider something like pre eclampsia, signs of which are easily monitored for at home.

My sister had a DVT in her leg about two/three years prior to her 4th pregnancy. She was on blood thinners as a result but a clot had developed in her liver - and was undiagnosed.

At full term she started haemorrhaging as a result of the clot and her daughter was stillborn.

The doctors didn't even diagnose it so it couldn't have been monitored!

It was closely and successfully monitored in her 5th pregnancy.

Oh Niki that's awful. My condolences to your sister.

The assay you should look into (half the equation, the other half is direct clot detection, usually done with ultrasound) is D-dimer. It may be challenging to miniaturise (though my experience is rather out of date so there may have been improvements made in the last couple of decades) because the levels being detected are ng/ml. Also, bear in mind that new methods may not be accurate so, before latching onto something that seems to promise a quantum leap forwards, look into validation studies. A good starting point would be what's called Point of Care (PoC) but these may well only be valid for screening and require further testing on more complex equipment.

D Dimer levels are elevated in pregnancy so cannot be used to reliably screen for DVT in pregnancy.
If you’re looking for ideas related to pregnancy or maternal healthcare you could start by looking at the confidential enquiry into maternal deaths report.

I am a bit confused as to what you mean by monitoring DVT op.
The current green top guidelines are the result of over 15 years of clinical research and audit across the whole of Europe and beyond. The volume of work and corresponding fund raising and political lobbying was extraordinary and is ongoing.
Antenatal screening is fundamental and is part of comprehensive antenatal care by appropriately trained midwives.
Screening tools were developed specifically to identify women at risk so they could be given appropriate thromboprophylaxis. Signs/ symptoms of VTE form part of routine ante and post natal care.
What would your product be and how would it be used?

D Dimer levels are elevated in pregnancy so cannot be used to reliably screen for DVT in pregnancy

I'm sceptical as to the practicality of continuous monitoring (given that the current target molecules I'm aware of, like glucose are at concentration ranges millions of times higher) but it seems like the issue is the difficulty in establishing a reliable normal range (given the variability) for point measurements to be of use. Continuous monitoring would allow for changes to be detected but that is 2 degrees of uncertainty off anything concrete (establishing monitoring capabilities then establishing the validity of monitoring).

The trouble is, d dimer levels can be raised for so many reasons, so testing anyone if there’s no clinical suspicion of VTE is a big no no. Throw pregnancy into to the mix and the levels go totally up the fuck, monitoring them for the average woman who isn’t at an increased risk would likely only lead to unnecessary trips to the hospital, overdiagnosis, and a whole lot of stress.

Continuous monitoring would allow for changes to be detected but that is 2 degrees of uncertainty off anything concrete (establishing monitoring capabilities then establishing the validity of monitoring).

Even with continuous monitoring, without reference values any changes would be meaningless. There aren’t really any established ranges, so before OP could even get started she’d have to comb through medical literature and try to come up with reference values for different gestations (and I’m sceptical that that would even be possible with the data available on the subject), which seems like it would be way outside the scope of what she is expected to achieve with this project.

I agree with endofthelinefinally, routine VTE screening is well established and generally works well, I’m not sure what a product could add to this. If I were you OP I’d pick a different (easier!) topic for your project.

SpuriouserAndSpuriouser I agree, delivering a polished product is well beyond a BSc project and even a PhD. I imagine it's probably closer to a decades long project for multiple teams, if it could even be worked into something usable at all. I was under the impression that a design project doesn't necessarily involve producing something that works immediately.

Have you seen a MALDI-ToF? Some 30 years ago, the upstarts were making pie in the sky claims about them being used in microbiology for speciation. That said, every idea that comes through is surrounded by a great number that didn't.

I know, the end goal is obviously not a totally finished product ready to launch, but presumably to do the project she has to identify a need and come up with a design for a product to fill that gap, and I just don’t think that a) there is a need, and b) that a product of this sort could feasibly monitor for DVT. I’m willing to be corrected as I know almost nothing about industrial development, my background is clinical, those are just the issues that jumped out at me.

I’m willing to be corrected as I know almost nothing about industrial development, my background is clinical

Sorry, that's an assumption on my part too, I do research on disease control. Though I haven't worked with industrial designers, I've seen very successful projects that hinged on 'if this capability can be developed' (though they are a rarity and take a special blend of realism and blue sky thinking).

Thanks for your responses everyone! As I mentioned, on a separate thread, someone previously mentioned that a product to monitor DVT would be really helpful. This person had experienced DVT in their 2nd pregnancy but unfortunately hasn't responded further which is why I've posted here, to gain more insight into this area. Now, I'm not entirely sure if this is a viable direction to go in but hoping that peoples experiences will clarify that for me When I originally did some research, I wasn't sure if it could be monitored (specifically for women being treated with this drug) by measuring Heparin levels, which is normally done in a clinical environment. But honestly, I have no idea!

@endofthelinefinally This is what another individual suggested I focus on, on a different thread of mine. I'm not really sure myself which is why I'm trying to get additional insights.

@Hearhoovesthinkzebras Thanks for your input, if I'm completley honest I'm not sure what exactly I'm looking to design either! I'll definitely look into pre eclampsia though, sounds like a more viable area to focus on.

@niki26 Wow, I'm so sorry to hear that, my condolences.

@Gronky Thank you for your response. I'll have to research more into this, but thanks for bringing it to my attention! I completely agree with you on checking out validation studies, your response has been really helpful! Referring to your latest post, the final deliverable isn't a polished product, instead we deliver an appearance model and proof of principle prototype where we can use existing technology to justify the design. We're not expected to deliver a fully functioning product within the year, which is why I'm choosing to aim at challenging areas for a design brief.

@Muststopfaffing Thank you, a great idea to look into maternal morality.

@endofthelinefinally Hi there, as I said this was a suggestion made by someone else, so I'm just trying to get further insights and have been doing as much research as I can to find out if this is a viable area to focus on. So I have no idea what I would want the product to do at this point, just trying to figure it all out!

@SpuriouserAndSpuriouser Thanks so much for your response. I think you're right, this subject area might be too tricky! Your post has been really helpful though in helping me understand what kind of scope I'd be looking at.

Just if anybody is interested, these are the other areas I'm currently looking at, it would be great to hear your thoughts.

1. Design a product to help alleviate pain from sufferers of endometriosis
2. Design a product to help new mothers and mothers to be, express, collect and store colostrum.
3. Design a product to engage more women in positive cervical screening experiences, through empowerment, familiarity and trust.

If anybody has other possible areas I could look at (like pre eclampsia as mentioned) that would be really helpful too.

Those are all really good ideas! I think the cervical screening idea in particular is good, it’s quite topical at the moment as uptake of screening has fallen in recent years, particularly amongst young women. There are home testing kits in development and I believe they are already in use in the Netherlands to some degree, so maybe something along those lines could be interesting for you.

Yes, 2 or 3 are both great ideas. Again I'm not sure that 1 is really possible, so many people like myself have so many different treatments and drugs, I don't think there is a one size fits all treatment.

@SpuriouserAndSpuriouser Thank you, I'm gland you think so! Thanks for the extra info too.

@HoneysuckIejasmine I completely agree that it wouldn't be a one size fits all solution. My friend who suffers from particularly bad symptoms has found that (aside from drug/surgery treatments) tens machines and heat therapy help her, however there aren't many available solutions that can be used discreetly outside the house. This is the kind of area I'd be hoping to look at, rather than a treatment, a discreet and portable device that women could use