Premature births are one of the most common causes of mortality and long-term disease in newborn babies worldwide. Assessing the risk of premature birth in a pregnant woman is not a perfect process. The most common diagnostic method is the determination of the shortening of the cervix via ultrasound. The determination of the length of the cervix is, however, not sufficiently sensitive enough for a foolproof diagnosis. We talked with Sabrina Badir, the founder of “Pregnolia.” Her start-up aims to revolutionize how the cervix is measured and to help avoid future premature births.
Sabrina Badir, with “Pregnolia” you want find out whether an baby is at risk for being born early. How do you do that?
You can imagine the uterus as a balloon. The cervix is the knot of the balloon, which prevents the child from being born too early. Therefore, the weakness of the cervix plays a central role in the diagnosis of a premature birth. Our probe also measures the stiffness of the cervix, an absolutely painless part of the procedure, and very reliable. A small probe is placed vaginally on the uterine cervix and a small portion of the tissue is sucked in by a few millimeters via a gentle vacuum, to measure cervical stiffness.
In Switzerland, approximately seven percent of babies are born prematurely. How does “Pregnolia” aim to reduce this number?
If gynecologists can identify preterm risks more accurately, they can react quickly and take preventive measures. Sometimes bedrest helps already, other women need hormone therapy to help stiffen the tissue, or some women need a so-called “Cerclage”, which is a supporting band around the cervical neck.
Is there a risk of measuring the tissue of the cervix during pregnancy?
There is no risk. The insertion of the probe and the slight vacuum are absolutely painless – most women don’t even notice that the measurement has been taken. This has already been confirmed in over 1000 measurements. The risk of damage to the tissue is the same as when a gynecologist touches the tissue with a finger.
You are currently looking for pregnant test subjects who are willing to measure the tissue of their cervix with your device. How many do you have so far?
The ongoing study is a cooperation between the ETH and the University of Zurich, where currently around 200 women have participated.
How many subjects do they need?
How do you look for these subjects?
The tests are being conducted at Unispital Zürich (Klinik für Geburtshilfe), in a few private gynecological practices in Zürich and in the cantonal hospital of Baden. The women are recruited directly through these centers.
Do you feel that women are afraid to get tested, because there are no long-term studies about your project?
No. What is important is that they have a good relationship based on trust with their attending doctor.
Aren’t you afraid that your product could be unreliable?
It is shown in the literature that women with a soft cervix have a greater risk for a premature birth. Since we measure a comparable parameter with our probe, we are very confident that we will achieve similarly accurate results and be able to demonstrate this with the measurements of the ongoing clinical trial.
What result do you expect exactly?
If the study runs as expected, the device gives clear indications of a premature birth as soon as a certain measured value is given. This would allow pregnant women to reliably exclude one of the many uncertainties of pregnancy.
How do you specifically address investors?
There are regular events for young entrepreneurs like us, where we can present our product to start-up investors.
It’s a delicate issue. Could this deter investors?
No, absolutely not. Many investors have children themselves and have had personal experiences with this topic. In contrast to a nicely designed app, most of the topics in the medtech industry are relevant to your own life or to someone you know. In addition, investors are not easily frightened people – otherwise, they would leave their money in the bank instead of investing in start-ups.
Where do you see your start-up at the end of the study, in two years?
Life in a start-up is so fast that two-year plans are hardly feasible. While I have ambitious goals, I have had to learn that it is better to move forward step by step. Perhaps in two years, we’ll be at a point where the majority of Swiss gynecologists use our probe. Perhaps we will be preparing for a market entry abroad, or for a new round of financing. Or we might change the device in such a way that early detection of successful start-ups is possible (laughs). Whatever the situation is, I look forward to the challenges coming our way.