Mental health treatment for women who are pregnant or lactating is crucial to ensure positive mental and physical health outcomes for both mother and baby; however, clinical trials often exclude pregnant and lactating women from studies because there are ethical concerns with using an investigational drug on these populations. This limits treatment options for this group, but the need for mental health therapeutics is real.
A retrospective cohort study of 100,000+ patients in the TRICARE claims database revealed that 35% of women were diagnosed with a new psychiatric condition during pregnancy or within one year of delivery.1 Mental health conditions not only impact a woman's quality of life, but can impact maternal functioning, potentially affecting her ability to care for herself and her child.
Addressing mental health concerns with medication could lead to better maternal mental health outcomes, reducing the risk of postpartum depression and other related disorders. If left untreated or undertreated; however, mental health conditions can have detrimental effects on both the mother and infant, potentially impacting bonding, development and long-term wellbeing. That is why it is vital to prioritize access to mental health medications during pregnancy and lactation.
Post-marketing follow-up studies of pregnant and lactating women using FDA-approved psychotropic drugs are necessary because pregnancy and lactation can significantly impact drug metabolism and distribution in the body, potentially leading to different pharmacokinetics and safety risks. Therefore, it is essential to find a means of studying the impact on this population.
May is National Mental Health Awareness Month, a time for raising awareness about mental illness and showing support. Real-world data (RWD) can be used to support maternal mental health clinical studies. By using RWD to conduct post-marketing studies, researchers can analyze the effects of mental health drugs on pregnant and lactating women, providing answers to regulators and helping healthcare providers make informed decisions about prescribing and managing these medications. However, it can be a challenge to connect the clinical data of mother and baby to understand long-term effects on both mom and child.
The HealthVerity Maternal Outcomes Masterset (MOM) uses advanced privacy-preserving techniques to synchronize the de-identified healthcare records of nearly 2 million pregnant women with their newborns while preserving critical data elements, such as race, birth events and pregnancy outcomes. Biopharma companies can use this pre-assembled, regulatory-grade, HIPAA-compliant and research-ready data to accurately and reliably map the patient journey for mother and baby, from pregnancy to postpartum, to support insights into the mental health of pregnant and lactating people in both commercial and Medicaid populations. MOM enables the evidence-generation biopharma needs, through retrospective analyses and prospective studies, to make a difference in maternal mental health.
Click here to learn more about how MOM can support your post-marketing studies in mental health therapeutics.
1 Andriotti, Tomas, MD, MPH, et al (2022). Psychiatric Conditions During Pregnancy and Postpartum in a Universally Insured American Population. Military Medicine, volume 187, issue 7-8, July-August 2022, pages e795-e801.