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The Fertile Area of Women’s Health -Part Three

The Fertile Area of Women’s Health -Part Three

09 Sep 11:00 by Julie McEwan

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In this three part blog I have investigated the devices on the market in the area of fertility and the abundance of technology now available for women to become more engaged in and to take greater ownership of their own fertility. I have looked at fertility enhancement and pregnancy prevention and the regulatory backlash for devices categorised in the latter.

In seems only natural, that in this concluding part, and given that I am now 8 months pregnant myself , that I look at the devices on offer for pregnant women, encompassing pregnancy symptoms, engaging with your bump, labour and top tech on offer for both Mums and babies post-partum.

Given the feelings of excitement, trepidation and nervousness that come hand in hand with pregnancy it is unsurprising that medical device and consumer markets have catered to this group of customers. I was surprised however at the range of products on offer and the innovation that is displayed, from more basic maternity support belts to smart nappies and wearable baby monitors that collect heart rate, temperature, oxygen saturation and sleep position/quality data. All of which can be analysed by parents via their existing smart phones. Some however, open discussions as to whether they have a place for use outside of the clinical setting, such as fetal heartbeat monitors and home ultrasounds. Do these, in the hands of an untrained user, cause more panic and distress than reassurance?

Pregnancy Devices

Some devices offer support for the less than desirable symptoms that come hand in hand with pregnancy. These include maternity support belts that can be purchased from local chemists to support the weight of the growing bump, redistributing the weight to ease back and ligament pain to the Relief band. An FDA approved device, worn on the wrist, that using neuromodulation blocks the body’s own neural pathways to turn off nausea. Although this device is not just marketed at pregnant ladies for morning sickness, but for sufferers of travel sickness also.

There is also a growing number of devices focused on sharing music with the unborn baby. Research in this area is increasing and initial reports suggest that from 20 weeks the baby can hear, and music played directly can have positive effects on the baby. These devices include a material belt, holding speakers which is worn around the pregnant belly and an earphone splitter which means that the same songs can be heard by the Mum whilst being played via to the baby. These devices, including Belly Buds and Sound Beginnings, have safety settings to ensure that the music is kept at a safe volume for the foetus. Research so far indicates that music heard in the womb will be recognised after birth and can lead to a more balanced sleeping pattern for the new-born. 

As technology advances it becomes more common in an everyday setting and the home environment is no different. On offer for expectant parents are fetal heart rate monitors and home ultrasound devices. These devices generally come with the advice from the manufacturer that their use and any home examination should not, in anyway, be used as a replacement for clinical testing and regular appointments with your midwife/doctor during pregnancy, but as an added extra. They also advocate seeking the input of your healthcare professional before investing in such a device.

I can see more parents to be consulting their doctor before investing in a home ultrasound kit, but some of the baby heart rate monitoring devices are available via smartphone application. Shell, developed by Bellabeat, consists of a free application that utilises the microphone in your phone to listen to the baby’s heartbeat. Other devices, including the FDA approved Little Beats Fetal Doppler is a monitor that can be used from 14-16 weeks of pregnancy to hear and record the baby’s heartbeat, movement and even its hiccups.

Home ultrasound machines are widely available, to purchase or rent. These include Butterfly IQ , which uses thousands of tiny sensors, mounted on a computer chip, which, in the same way that a bat uses sound to locate objects, can build an image of a human body from the inside out. This device connects to an iPhone and was originally developed by an innovative father who had to take his daughter to the hospital regularly for ultrasound scan of cysts in her kidneys. It is also now marketed for fetal ultrasound scans. Or Babywatcher, produced in the Netherlands and claiming to be the first ultrasound device developed for home use, this company offers the rental of such devices on a pay as you scan basis.

There have been warnings on the use of these devices in the home setting by people not clinically trained. In rare cases the excessive use of ultrasound can cause an increase in tissue temperature and rarer still small bubbles (cavitation) to form. Also, the increasing paranoia and stress caused by not being able to detect a heartbeat or an untrained eye viewing an ultrasound was also deemed to be highly detrimental to the welfare of the expectant parents, in terms of stress and worry.

Other companies are offering a holistic view in terms of support for pregnancy. Founded in 2014, Baby scripts are a digital platform, used in partnership between patient and health care professionals, in order to offer a complete toolkit for tech-enabled prenatal and postpartum care. The healthcare professional configures the application according to what information and features they feel will be of the most benefit to the patient, via the app they can access information, videos and clinical education documents and are set certain specific modules to read. In addition to this the patient is sent connected medical devices so that real time information can be accessed and assessed by the doctor, thus if the need arises then intervention can be swift and tailored. This partnership also makes the parents to be feel more engaged, informed and actively involved during the pregnancy. All appointments and monitoring in between is managed via the app, making the process streamlined and more convenient.

Devices for Use in Labour

Obviously once a woman is in labour, they will spend much of the duration in a clinical setting, so there are fewer developments in this stage when compared to the proceeding 9 months. That being said, there are devices that can be used to assist.

Bloomlife is a contraction count and timing monitor that can assist labouring mothers understand when they have begun to have contractions, the duration and intensity of them and track the time in between. This is all useful information not only for the mother but also the hospital once she is admitted. At this exciting but nervous time, it is not unreasonable for the labouring mother not to be able to record and retain this information accurately, but also the data may be distorted by recording of information relating to episodes that are not actually contractions. The device transfers all data to the patient’s smartphone to be recorded.

Pain management relief is also on offer from a variety of companies manufacturing TENS (transcutaneous electrical nerve stimulation) machines. Although not every TENS machine can be used during pregnancy a definite market exists for their use in labour. These devices are safe non-invasive, drug-free methods of pain management. Attached to the mother via electrode pads, most commonly to her back, the device delivers a small electrical impulse that can reduce the pain signals going to the spinal cord and brain, helping to relieve pain and relax muscles. Also stimulating the release of natural endorphins, further helping with pain relief.

The other device that caught my eye whilst researching this stage of the process is one that is not used by the patient, but by a healthcare professional and is also used post-partum. The reason that I am including it is that the device focuses on a serious problem and addresses an area that has previously utilised the same solution for many years. This device is called the PPH Butterfly and has been developed by the university of Liverpool following a substantial grant from the National Institute for Health Research. It is used to control and stop post-partum haemorrhage, which is the most common maternity emergency experienced in the UK in the 24 hours following birth. Globally though, it is responsible for many deaths.  

Currently the technique used to manage this is very invasive and involves the manual manipulation of the uterus to make it contract and to stop the bleeding. This is performed internally with one hand and externally with the other, causing significant discomfort for the mother and a very labour-intensive process for the Doctor. The PPH Butterfly is a device which is inserted vaginally, and the uterus is contracted internally using the device. The device continues to progress through clinical trials, but it is the first alteration to the approach by healthcare professionals for some time and although the underlying process is still the same the development of this device (which is cost effective) makes the application more comfortable for the mother and the healthcare professional.

https://innovations.bmj.com/content/3/1/45

Devices Post-Partum – Baby

Most devices for the new-born baby focus on monitoring the health and wellbeing of the baby, as has always been the case. The onward march of technology now offers a wider range of products that can detect and measure an ever-increasing number of factors.

Baby monitors still exist in their audio and video form but now most work in conjunction with a wearable item that measure physiological factors, these include heart rate and breathing rate. In the case of Nanit which combines a breathing band and a baby swaddle or in the case of the Owlet Sock, oxygen saturation, skin temperature and also sleep position and quality. As in previous examples all the data is transferred to an accompanying app viewed on a smart phone. Owlet have also produced a video baby monitor that due to its wide-angle lens can also record and chart room temperature and audio levels.

 Sproutling have developed a device that is suitable for babies 6 months and up that will measure similar factors as to the above, but based on algorithms developed form previous data, will predict when a baby will wake. Baby Guard Monitor is a smart mat sleep monitor which is placed within the baby’s cot and will detect and display the baby’s breath count, sounding an alarm to alert parents of waking breath movements, but also irregular patterns or a cessation in breathing.

Monitors for baby temperature can also be used in conjunction with a wearable. Temptraq is a patch like smart device that sticks to the baby’s skin under the armpit and will record data on a 24/7 basis. Perhaps the most amazing devices I found during my research for baby monitoring were Guardian Animals and Pixie Scientific.

Guardian Animals are a range of stuffed toys that have biosensors in their paws, which when touched by the child will record factors such as body and room temperature, heart data and blood oxygen level. The thought process being that the child’s play should not be interrupted to take such measurements with more traditional devices and that they can still be monitored by parents. Pixie Scientific offer the first smart nappy. On the back is a QR code and test strips which measure the baby’s health via urine analysis. The data can be accessed via the QR code and includes measures of hydration, indications of kidney function and the presence of any urinary tract infections.

Devices Post-Partum – Mum

Devices in this area again seem to focus on the same areas as before, but just have new twists thanks to technology. These are namely, feeding of baby and the ability to express milk.

The much acclaimed area of wearable breast pumps has received a lot of media attention and pumps such as Elvie and Willow, that fit snuggly within a nursing bra and very quiet allow women to express milk on the go. Product feedback on both websites speaks of women expressing milk whilst at their desks or on public transport, without any inhibition or awareness from anyone else around them. These battery-operated devices have no tubes that need to be cleaned and express directly into the milk storage bag, stopping automatically once full. The accompanying app also records tracking information regarding the volume of milk expressed and from which breast, also boasting remote control of the pump.

Through my research I also came across a scheme called Maven Milk, and this was perhaps the most innovative and progressive solution for breast feeding mothers. This scheme focuses on mothers that must travel for work and how they cope with expressing once they return. This scheme is one that offers breast milk shipping in the US. Through the use of three different kits the mother can decide to pump and post, pump and carry or pump and check their breast milk. All factors have been covered, so if she opts for pump and post the milk is stored in a medical grade refrigerated shipping kit, the pump and carry includes airport security (TSA) recognised and approved containers so there will be no embarrassment whilst travelling through the airport and the pump and check option includes a Durable Coleman cooler with antimicrobial liner that keeps the milk frozen for up to 24 hours. This scheme has been such a success in the US that large corporations are beginning to include it within their benefit package for employers.

 

It is exciting to see how far technology has come in this market sector and let’s face it, anything that makes life easier, less stressful and makes parents to be more engaged with their pregnancy and ultimately their baby has got to be a good thing. It is just finding the budget for it all……………………………….