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SMART Diaphragm: Changing the Way Doctors Detect High-Risk Pregnancies

Pre-term births can result in dangerous deliveries for mothers and life-long medical problems for children. Currently, one in ten babies are born prematurely, but a new project called SMART Diaphragm is working to change this through an early detection system.

SMART Diaphragm is an early warning system for high-risk pregnancies. Pregnant women insert a sensor-enabled diaphragm that monitors changing collagen levels in the woman’s cervix. The results are wirelessly transmitted via bluetooth-enabled phones to a cloud data storage system. spoke with Dr. Larry Rand, Director of Perinatal Services of the Fetal Treatment Program at the University of California San Francisco and Mozziyar Etemadi, who is pursuing an MD and a PhD in Bioengineering at UCSF’s Medical Scientist Training Program about their work developing the Smart Diaphragm project, and why the project fills a niche in maternal health.

Rand explains that the SMART Diaphragm development team, comprised of both bio-engineers and obstetricians who focus on high-risk pregnancies, wanted to use a diaphragm to collect data after realizing that it was an accessible and recognizable tool. He says, “We went through a couple of iterations before we came up with the idea – would it be something you could use in the office, would it be something you would use at home, is it something you could use locally in the developing world and here? And slowly but surely we came up with the idea of the diaphragm."

The SMART Diaphragm sits on the cervix and takes measurements of collagen levels intermittently (dependent on the needs of the pregnancy); those measurements are sent to a cloud database, ultimately creating a tracking system that doctors can use to predict potential problems with the pregnancy.

Rand adds, "What makes it a SMART Diaphragm, as opposed to a regular diaphragm, is that a regular diaphragm acts as a barrier, as a cap to the cervix and as a contraceptive. In pregnancy, you certainly aren’t worried about contraception – what makes it a SMART Diaphragm is that it has sensors embedded in it that will help measure the collagen changes in the cervix before you would ever recognize actual symptoms."

The Technology

Etemadi, one of the bio-engineers working on the project, explains that making the project accessible and affordable was a huge focus during the development phase. He says, "For a bio-engineering standpoint, the unique thing about this project is it leverages a lot of existing technology. […] We wanted to make this as cheap and as sustainable as possible." The device can transmit the data to the cloud after coming into contact with any bluetooth-enabled phone, so users do not need to own their own phone in order to use the Smart Diaphragm.

Etemadi says, “In the developing world, this is really revolutionary. You could have hundreds of women who are able to wear a diaphragm like this that they can insert themselves or remove themselves, and don’t need a physician, they don’t need an exam in order to have the results read, all they need to do is come into contact with someone in the community who has a bluetooth-enabled phone. It could be as simple as a community health worker or a community point person who can ‘read’ the results and transmit that to the cloud." In this way, women aren’t dependent on visiting doctors or health centers (which could be far away), as their data can be uploaded regularly and remotely, with alerts sent to doctors if collagen levels change. He adds, “The idea is that it doesn’t require advanced networks, it’s very basic data transmission and can be working off a very basic cellular infrastructure."

Use and Testing

According to Rand, there are four main factors that contribute most frequently to pre-term births: 1) a previous pre-term birth, 2) multiple gestation (twins, triplets, etc…) 3) previous cervical surgeries/lacerations/uterine abnormalities and 4) maternal smoking.

Rand says that the device is only meant to be used for women who are at high-risk for a pre-term birth; pilot testing has started in the US, and the team plans to deploy a control trial (testing the efficacy of Smart Diaphragm compared to traditional doctor care) in either South Africa or Liberia later this year. SMART Diaphragm recently won second place at the Vodafone Americas Foundation Wireless Innovation Project and the mHealth Alliance Award, recieving more than $200,000 to continue work developing and deploying the project.

The most revolutionary part of SMART Diaphragm is its ability to register minute changes in collagen levels in order to create an early warning system, giving pregnant women time to get medical care before they go into an early labor. Premature births can result in higher rates of chronic diseases (such as cerebral palsy and respiratory illnesses) as well as higher rates of sensory deficits, learning disabilities and early mortality among pre-term birth children, compared to children born at full-term. Helping pregnant women carry their children to full-term will result in healthier lives for the children and mothers. Rand concludes, "Right now, women go to great lengths women during a pregnancy to get screened for any sign of an issue, and unfortunately those signs can be found way too late. So we need to think outside the box and go back several steps to the silent parts of this disease and how to detect it at that point."

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