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Open research questions in Pregnancy and Medication Impact

265 gap statements mined from Pregnancy and Medication Impact papers in our 7.9M-paper local library, which holds 1,571 papers on the topic — drawn mostly from each paper's own stated research gap, future-work, challenge and limitation notes, and its abstract. The ones listed below are a selection still marked open; each names the study that raised it, with a DOI link where the paper has one.

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What the literature leaves open

  • The lack of characterization of pregnancy outcomes in women with rheumatologic diseases and neurologic involvement. The need to understand the disease-specific case series of pregnancy outcomes in women with SLE, Sjögren's disease, and sarcoidosis with neurologic involvement. The importance of considering neurologic involvement in the management of rheumatologic diseases during pregnancy.

    Pregnancy outcomes in women with rheumatologic diseases and neurologic involvement · 2026 · DOI

  • There is a lack of knowledge on the effects of ketamine and esketamine on breastfeeding and infant outcomes. Prior studies have not provided sufficient evidence on the transfer of these drugs into human milk and their effects on infant exposure and breastfeeding outcomes.

    Ketamine and esketamine during breastfeeding: a systematic review of human pharmacokinetic, infant and lactation outcomes · 2026 · DOI

  • The impact of rheumatic diseases on pregnancy is not fully understood. There is a lack of comprehensive data on the risks and complications associated with rheumatic diseases during pregnancy.

    Infectious comorbidities in pregnant patients with rheumatic diseases · 2026 · DOI

  • One challenge is the impact of pregnancy on the pharmacokinetics of medications. Another challenge is the need for therapeutic drug monitoring (TDM) to manage psychiatric disorders during pregnancy.

    Dealing with the impact of pregnancy on the pharmacokinetics of aripiprazole once-monthly · 2026 · DOI

  • Further studies are needed to quantify the impact of pregnancy on the pharmacokinetics of aripiprazole LAI. Studies should investigate the risk of lactation failure, previously reported for aripiprazole, and/or potential dose-dependent patterns. Research should focus on the management of schizophrenia during pregnancy and the use of TDM to avoid subtherapeutic drug levels.

    Dealing with the impact of pregnancy on the pharmacokinetics of aripiprazole once-monthly · 2026 · DOI

  • Most previous studies have assessed benzodiazepines as a drug class, with limited evidence regarding their dose, half-life categories, or individual agents. There is a need to evaluate the dose-response, half-life classification, and individual agents of benzodiazepines.

    Benzodiazepine exposure during early pregnancy and risk of miscarriage: dose–response, half-life classification, and individual agents · 2026 · DOI

  • However, infant clearance following in utero exposure remains unknown, and data on placental transfer are scarce.

    Limited placental transfer and clearance of risankizumab by 6 months following in utero exposure · 2026 · DOI

  • Immune mediated inflammatory diseases (IMID) affect women of childbearing age, yet there is a lack of evidence about the risk of adverse pregnancy outcomes and the interaction with medication.

    Medication use during pregnancy and pregnancy outcomes in women with immune mediated inflammatory diseases: a UK-based matched cohort study · 2026 · DOI

  • Women using ADHD medications had an elevated incidence of cardiometabolic conditions during pregnancy, but it remains unclear to what extent this is attributable to medications rather than the underlying ADHD.

    Attention-deficit/hyperactivity disorder medication use and cardiometabolic conditions in pregnancy: a population-based cohort study · 2026 · DOI

  • Data on the effect of this medication on maternal Tdap (Tetanus-Diphtheria-acellular pertussis) vaccination and transfer of antibodies to the infant are scarce.

    Impact of immunomodulating medication on maternal Tdap vaccination-induced antibodies in infants · 2025 · DOI

  • The pharmacokinetic (PK) profile of vedolizumab during pregnancy is not fully characterised, though concentrations have been reported to drop1.

    P0671 Supporting vedolizumab treatment throughout pregnancy: Insights from a population pharmacokinetic model · 2025 · DOI

  • There is limited data on the extent of psychotropic medication exposure through breast milk in infants.

    Psychotropic Medication Exposure via Breast Milk: A Population‐Based Descriptive Study in Denmark · 2025 · DOI

  • More than a third of fathers filled at least one prescription medication in the preconception period, and several of them are known to be embryotoxic, emphasizing the necessity for further investigation into the potential teratogenicity of paternal exposure.

    Patterns of paternal medication dispensation around the time of conception · 2024 · DOI

  • Past research on the safety of prenatal exposure to medications has focused on maternal use during gestation, with limited research into the potential effects of paternal use during the spermatogenic period preceding conception.

    Patterns of paternal medication dispensation around the time of conception · 2024 · DOI

  • Whether single and combined use of these medications is associated with spontaneous preterm birth (sPTB) remains unclear.

    Opioid analgesic and antidepressant use during pregnancy and the risk of spontaneous preterm birth: A nested case–control study · 2024 · DOI

  • Rheumatic diseases may impair reproductive success and pregnancy outcomes, but systematic evaluations across diseases are lacking.

    Patterns of reproductive health in inflammatory rheumatic diseases and other immune-mediated diseases: a nationwide registry study · 2024 · DOI

  • Data about hydroxychloroquine (HCQ) levels during pregnancy are sparse.

    Hydroxychloroquine levels in pregnancy and materno-fetal outcomes in systemic lupus erythematosus patients · 2024 · DOI

  • Likewise, the in vitro methods to enable reliable PBPK predictions in these special populations are not well characterized.

    EMA perspective on the value of model‐informed drug development for labeling recommendations regarding medicine use during pregnancy and breastfeeding · 2024 · DOI

  • There is a lack of comprehensive evaluation of the efficacy and safety of non-pharmaceutical Chinese medical therapies for nausea and vomiting of pregnancy. There is a need to evaluate the certainty of evidence using the GRADE criteria.

    Non-pharmaceutical Chinese Medical Therapies for Nausea and Vomiting of Pregnancy: An Umbrella Review of Systematic Reviews and Meta-analyses of Randomized Controlled Trials · 2026 · DOI

  • The use of black box models can be a limitation due to the lack of control and potential biases. The need for more data is a limitation of using AI to close the evidence gap. The opacity of certain artificial intelligence models is a concern.

    How Machine Learning Can Help Close Evidence Gaps for Drug Safety in Pregnant Women · 2026 · DOI

  • The current methods for determining medication safety in pregnant women are limited.

    How Machine Learning Can Help Close Evidence Gaps for Drug Safety in Pregnant Women · 2026 · DOI

  • It is known that pregnancy affects disease activity in Rheumatoid arthritis (RA), but earlier studies have shown conflicting results regarding the degree of change and the role of antibodies.

    The biologic era and pregnancy in rheumatoid arthritis: a prospective multicenter study from the Norwegian RevNatus registry · 2026 · DOI

  • There were only 30 applicable studies and therefore these studies may not be representative of the entire body of post-marketing pregnancy safety studies.

    Outcomes of post-approval non-interventional safety studies in pregnancy: wide variation demonstrates need for further standardization · 2026 · DOI

  • Further studies are needed to characterize the disease-specific case series of pregnancy outcomes in women with SLE, Sjögren's disease, and sarcoidosis with neurologic involvement, - Research should focus on the shared presence of neurologic involvement across autoimmune…

    Pregnancy outcomes in women with rheumatologic diseases and neurologic involvement · 2026 · DOI

  • Studies on infant plasma concentrations or long-term neurodevelopment are needed - Research on repeated intranasal esketamine exposure…

    Ketamine and esketamine during breastfeeding: a systematic review of human pharmacokinetic, infant and lactation outcomes · 2026 · DOI

Most-cited papers in Pregnancy and Medication Impact

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Open questions raised by papers listed on this page include: (1) The lack of characterization of pregnancy outcomes in women with rheumatologic diseases and neurologic involvement (“Pregnancy outcomes in women with rheumatologic diseases and neurologic…”, 2026); (2) There is a lack of knowledge on the effects of ketamine and esketamine on breastfeeding and infant outcomes (“Ketamine and esketamine during breastfeeding: a systematic review of human…”, 2026); (3) The impact of rheumatic diseases on pregnancy is not fully understood (“Infectious comorbidities in pregnant patients with rheumatic diseases”, 2026); (4) Further studies are needed to quantify the impact of pregnancy on the pharmacokinetics of aripiprazole LAI (“Dealing with the impact of pregnancy on the pharmacokinetics of aripiprazole…”, 2026); (5) There is a need to evaluate the dose-response, half-life classification, and individual agents of benzodiazepines (“Benzodiazepine exposure during early pregnancy and risk of miscarriage:…”, 2026). 265 gap statements have been mined from Pregnancy and Medication Impact papers in our 7.9M-paper local library, which holds 1,571 papers on the topic; the gaps come from whichever of those papers state one. They are mostly the research gaps the authors state and the papers' abstracts, plus future-work, limitations and challenges passages. The ones listed below are a selection still marked open; each names the study that raised it, with a DOI link where the paper has one, so you can read the original claim in context.

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