Electronic Lab Notebooks Help Evaluate the Safety of Common Pharmaceuticals for Pregnant Women


Once pregnant, women are often left wondering whether or not it is safe to take common pharmaceutical medications. More researchers than ever are undertaking studies to try to answer their questions. Image Credit: Flickr user Philippe Put

There is a dearth of information about the safety of pharmaceutical drugs for women who are pregnant. The CDC estimates that 70% of pregnant women in the United States were previously taking at least one prescription drug, but only about a dozen medications have been approved for safe use by the FDA.1 In addition to the general lack of research in the field, there are also inconclusive association studies that raise questions about certain medications’ safety without providing definitive answers.

This has left many women unsure about whether to continue taking their regular medications, torn between concerns about the safety of the baby and their own health during their pregnancy. To provide these women with better medical advice, many researchers are undertaking studies that probe the safety of common pharmaceuticals for pregnant patients and their children. There are two different types of studies that can be conducted: studies that analyze previous medical records, and studies where pregnant patients are identified in advance and then monitored over the long-term. Both types of research can benefit from and be supported by electronic lab notebooks.

Analyzing Previous Records to Draw Conclusions About Pharmaceutical Safety

In January 2017, researchers from Aarhus University in Denmark published a paper in the international journal BMJ Open indicating that taking anti-epilepsy medications during pregnancy does not harm the health of the child. To analyze the safety of anti-epilepsy drugs for pregnant patients, they evaluated records that had been collected on over 4,400 pregnancies between 1997 and 2012. Ultimately, they found that there was no significant difference in the number of doctor’s office visits for children whose mothers had taken anti-epilepsy drugs during pregnancy and those whose mothers had not, which indicates that the drugs had no effect on their overall health.2

That’s good news for pregnant women who use the drugs to control epilepsy, as well as those who take them to treat chronic migraines or bipolar disorder. And the paper also paves the way for more pharmaceutical safety studies that rely on large-scale data analysis. Electronic lab notebooks can support this work, allowing scientists to store and easily access thousands of medical records with information on a wide range of relevant factors. For instance, when considering the safety of anti-epilepsy drugs, the researchers at Aarhus University factored in the child’s gender and birth date, as well as the mother’s age, income, education level, medical history and family situation.3 Only by accounting for these medical and demographic characteristics can researchers be sure that they are providing pregnant women with reliable pharmaceutical safety advice.

Long-Term Health Monitoring Studies

Another way to assess the safety of a pharmaceutical drug is to monitor the health of the mother and the child after the patient chooses whether or not to continue taking a medication during her pregnancy. That’s the approach that Dr. Uma Mahadevan, a gastroenterologist at the University of California in San Francisco is taking. She works with patients who have inflammatory bowel disease.

Some of her patients continue to take their prescription medications during pregnancy, while others give it up due to concerns about the fetus’s safety. But that too can be risky, because if the patient’s inflammatory bowel disease acts up, they may be forced to take steroids or have surgery. In an effort to better understand outcomes for women who do and do not take inflammatory bowel disease drugs while pregnant, Mahadevan’s research group followed 1500 patients, and their preliminary findings show that there was no increase in birth defects when mothers continued to take medication for inflammatory bowel disease.4

However, their work isn’t done yet. The group plans to monitor the children’s health until they are four years old.5 After all, it is critical to make sure that taking a drug will not only ensure that the baby is born healthy, but also that the child won’t have significant health problems when they grow older.

When monitoring studies like these in the long-term, using electronic lab notebooks can be extremely helpful, because they make it easy to manage data for long periods of time. Unlike the paper-based lab notebooks of the past, electronic versions simplify information organization and accessibility. Instead of having to search through notebook archives for key information, scientists can easily locate the data they need for research decision-making, even if it was collected years before.

Supporting Broader Research Collaborations

Another significant advantage of electronic lab notebooks is the facilitated interactions between researchers who have expertise in many different areas. When studying the safety of pharmaceuticals for pregnant women, it is critical to get the perspectives of specialists in obstetrics and gynecology research and treatment, as well as doctors who focus on whatever disease or condition a patient is trying to treat with a particular drug. It can also be helpful to bring in data and insights from pharmaceutical chemists and drug developers. Electronic lab notebooks make it easy for these professionals to share their results, and it also provides a high level of protection for sensitive patient data. That way, even when studies run for years and data is circulated between multiple researchers, there are no concerns about third-party access or security breaches that lead to data deletion.

While research efforts related to pharmaceutical drug safety for pregnant women are promising so far, there are far more drugs to evaluate. By helping improve the overall efficiency and quality of the research process, electronic lab notebooks can help doctors and scientists find answers for women who have to decide whether to take prescription pharmaceuticals while pregnant.

BIOVIA Electronic Lab Notebooks support information organization and accessibility, as well as collaboration between researchers without compromising security. Contact us today to learn how this technology can revolutionize research and development efforts in your lab.

  1. “When pregnant women need medicine, they encounter a void,” August 8, 2016, http://www.npr.org/sections/health-shots/2016/08/08/486907088/when-pregnant-women-need-medicine-they-encounter-a-void
  2.  “Prenatal exposure to antiepileptic drugs and use of primary healthcare during childhood: a population-based cohort study in Denmark,” January 2017, http://bmjopen.bmj.com/content/7/1/e012836
  3. “Anti-epilepsy medication taken by pregnant women does not harm the child’s overall health,” February 16, 2017, http://newsroom.au.dk/en/news/#news-9962
  4. “When pregnant women need medicine, they encounter a void,” August 8, 2016, http://www.npr.org/sections/health-shots/2016/08/08/486907088/when-pregnant-women-need-medicine-they-encounter-a-void
  5. “A multicenter national prospective study of pregnancy and neonatal outcomes in women with inflammatory bowel disease,” https://clinicaltrials.gov/ct2/show/NCT00904878