This may come as no surprise. Afterall, it wasn’t even until 1993 that Congress directed that “women were to be included in all federally funded clinical investigations, unless inappropriate” (1). Meaning, prior to 1993, people with a uterus didn’t need to be included in clinical trials, even for medications specifically geared towards them. For example, in a study of Addyi (which is basically viagra for women*) and its interaction with alcohol, only 2 women* were tested- the rest were men (15). WTF?!
It’s almost too ridiculous to be true. But we kid you not. How did this fly? Researchers believed it didn’t matter. They believed that data from penis-having bodies could be applied to uterus-havers too. Yet, 80% of drugs are taken off the market because of their side effects on women* (14).
Another big reason? The menstrual cycle. Research is expensive to begin with, and uterus-havers can be more costly if their menstrual stage has to be controlled for in the study (14), or if their fluctuating hormone levels get in the way (because penis-havers don’t have hormones, right?!) Plus, if uterus-havers were to get pregnant during the study, it may make them no longer a viable subject.
So, with all that said, you can imagine just how hard it is to have pregnant bodies purposefully included in research, when, in addition to all of the above, the default assumption has for so long been that we need to protect pregnant people and their fetuses from research, rather than use research so they can benefit.
This mindset has not been without consequences. Most of the prescription medicine taken during pregnancy has not been studied on pregnant bodies at all (1), even though about 60% of pregnant people use some sort of prescription medicine during their pregnancy (1).
Remember the DES scandal of the 1950s-70s- where medication was prescribed to pregnant people to prevent miscarriages, but ended up causing them instead? It also caused millions of babies to be born with genital and reproductive tract defects, leaving them infertile and at a higher risk for cancer. Between 5-10 million uterus-havers were prescribed this drug, with many not even being told what they were given (14), even though DES was banned by the FDA for having devistating effects on male* agricultural workers who had been exposed.
There is just so much about pregnancy overall that we still don’t know … including the hows and whys labor begins- which is why it is so vital that this mindset changes.
And it’s starting to! In January 2019, an updated federal policy officially removed pregnant people from being listed as “vulnerable to coercion or undue influence” (17). Which means, there is opportunity on the rise for pregnant people to actually be studied. And, because change on an institutional level is slow, there are people taking matters into their own hands in the meantime.
Meet Bloomlife. Bloomlife is a contraction tracker and app that allows the user to monitor their contractions in real-time. This puts the power in the hands of the pregnant person because they get to see their data directly, allowing them to more easily take part in conversations around their body. :high five:
Not only is this tool useful for the individual, but for the collective. Why? Bloomlife’s goal is to define physiological biomarkers that provide clinical value for maternal health and prenatal care.
And with that, they just completed the very first high quality, longitudinal study of its kind in less than two years (!!) to identify their first set of biomarkers — uterine muscle activity combined with maternal heart rate parameters– to help detect labor. (read more about it here!)
Their dataset includes 10,000 pregnant people and over 360,000 hours of data recording, across the United States that was donated by a diverse population of people, without geographic or care provider restrictions. This means that all data collected was done so with consent. Hell yeah!
Why is this important? According to Dr. John Elliott, MD, MFM,
“Preterm delivery rate has not changed substantially in the last 50 years. One of the biggest problems is that we don’t really know how to predict labor at term, let alone be able to extrapolate that to the more important time frame — preterm labor.” (4)
Preterm birth is when a baby is born before 37 weeks of pregnancy. The brain, lungs, and liver need the final weeks of pregnancy to fully develop so babies born too early (especially before 32 weeks) have higher rates of death and disability. In 2017, preterm birth affected about 1 of every 10 infants born in the United States (16) and the rate of preterm birth among African-American people was about 50 percent higher than the rate of preterm birth among white people (18).
These biomarkers will be used to better understand preterm labor and fuel new research for pregnant people.
Written by: Catherine Work
*language used in studies