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Open research questions in Pregnancy and Medication Impact

41 unresolved questions extracted from the limitations and future-work sections of 705 Pregnancy and Medication Impact papers in our library. Each links back to the study that raised it.

What the literature leaves open

  • Further studies with more extensive FGDs, including participants from a wide range of socioeconomic status, are recommended. Further study may focus on a specific trimester of pregnancy or the postpartum period to enable further comparison of HRQoL and to assess possible correlations in the results. Documentation of the presence and frequency of venous and/or arterial thrombosis among participants should also be included in future studies. For the content analysis, an independent analysis from a second investigator may be recommended.

    Health-Related Quality of Life during Pregnancy of Filipino Patients with Antiphospholipid Syndrome in Philippine General Hospital · 2026 · DOI

  • Willingness to share EHR data varied widely (22-100%), with governance safeguards, trust in institutions and participant control strongly influencing acceptability.

    Enabling real-world evidence for medication safety in pregnancy: Determinants of research participation and linked EHR data use · 2026 · DOI

  • Abstract Background 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

  • As previously described in detail, general limitations inherent to observational cohort studies conducted by Teratology Information Services, such as selection bias or response bias, must be considered67. Furthermore, due to the limited sizes of the exposed sub-cohorts, any risk calculations would lack sufficient statistical power, and comparisons with control groups would not be statistically valid. For illustration, detection of a fivefold increase in the overall rate of major birth defects would require approximately 85 exposed pregnancies per group, assuming a baseline prevalence of 3% (α = 0.05, 80% statistical power, two-sample comparison). Even our largest subgroup, 75 live-born infants exposed to mebendazole in the first trimester, is therefore not suitable to detect such an increase. Detection of specific birth defects, such as cardiac anomalies with a baseline prevalence of ~ 1%, would require substantially larger cohorts. Consequently, our analysis was limited to descriptive evaluation and detection of risk signals rather than quantitative risk assessment. The confined case number and the absence of a comparator group are key limitations of this study and limit the interpretability of the observed rates. Where comparisons with the general population prevalence rates are referenced, these are provided solely for contextual orientation. We are aware that the Embryotox cohort is not comparable to the general population in all characteristics, as e.g. the level of education is known to be higher68. Reported co-medication and other factors (such as genetic predisposition) may additionally influence the pregnancy outcome. Furthermore, confounding by indication cannot be excluded, due to heterogeneity of underlying parasitic infections and their respective treatment protocols. It is challenging to disentangle these different aspects from the underlying drug effect. Despite these limitations, the Embryotox study offers several notable strengths that set it apart from previously published data. Data were prospectively collected according to a standardized internal protocol to ensure consistency and high quality. Detailed medication histories were obtained, including dosing regimens, concomitant therapies, maternal characteristics and relevant potential risk factors. All congenital anomalies were classified in a blinded manner by two independent experts from our institute, minimizing the likelihood of misclassification bias.

    Anthelmintic medication with focus on first-trimester exposure: an evaluation of pregnancy outcomes based on the Embryotox cohort · 2026 · DOI

  • Beyond associations: Navigating the safety of non-steroidal anti-inflammatory drugs (NSAIDs) in early pregnancy Andrew S. C. Yuen 1,2, Kenneth K. C. Man 1,2* 1 Research Department of Practice and Policy, School of Pharmacy, University College London, London, United Kingdom, 2 Centre for Medicines Optimisation Research and Education, University College London Hospitals NHS Foundation Trust, London, United Kingdom * [email protected] Pain and fever in pregnancy require treatment, but fetal safety concerns complicate analgesic choice. A recent PLOS Medicine study presents new evidence on the safety of first-trimester NSAID use and congenital malformation risk, but interpreting findings across studies is challenging. OPEN ACCESS Citation: Yuen ASC, Man KKC (2026) Beyond associations: Navigating the safety of nonsteroidal anti-inflammatory drugs (NSAIDs) in early pregnancy. PLoS Med 23(6): e1005129. https://doi.org/10.1371/journal.pmed.1005129 Published: June 4, 2026 Copyright: © 2026 Yuen, Man.

    Beyond associations: Navigating the safety of non-steroidal anti-inflammatory drugs (NSAIDs) in early pregnancy · 2026 · DOI

  • The following limitations should be considered when reviewing the conclusions from this work. First, the sample size of total studies evaluated was small, and subgroups of these studies were even smaller. There were only 30 applicable studies and therefore these studies may not be representative of the entire body of post-marketing pregnancy safety studies. Further there were only 4 FDA studies done before 2019 and 4 vaccine studies overall, which made it difficult to draw conclusions for some assessments. The small sample size of total studies may be caused by a few factors: (1) Not all studies in the HMA-EMA catalogue were included due to a lack of a publicly available protocol, which limited our review. It is possible that studies that included a publicly available protocol may have been different from studies that did not. However, a protocol was required to identify all the study outcomes for this analysis. (2) The studies included in this review relied on the built-in filters on the HMA-EMA catalogue. If a study measured pregnancy outcomes in the pregnant population but was not properly labeled as such in the catalogue, it may have been excluded based on the filters applied in Figure 1. It is possible that other technical issues within the site may have provided a smaller sample size than intended. (3) This review excluded data from spontaneous case reports which may have omitted several studies and their outcomes. This criterion was necessary to restrict to studies with pre-defined outcomes. Studies using spontaneous case report data often are designed to report any adverse outcome occurring in pregnancy and thus the outcomes that are summarized in the final report are determined by the outcomes observed in the reported cases, rather than a predefined outcome list. (4) Sponsors may have variations in their policies regarding whether a study needs to be registered in the the EMA requires all post- HMA-EMA catalogue.

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

  • View of Volume 66, Special Issue, September 2021 Although the inclusion of pregnant women in clinical research has been widely promoted over the last decade, there is still a lack of evidence-based knowledge concerning risk and efficacy of medications used for obstetric and non-obstetric illnesses.

    Oral Presentations Abstracts: ADDRESSING THE EVIDENCE GAP IN MEDICATION FOR PREGNANT WOMEN: THE NEED FOR MORE SOLIDARITY? · 2021 · DOI

  • INTRODUCTION: Numerous studies have been performed assessing optimal treatment regimens for evacuating (retained) products of conception from the uterus, but standardized criteria for diagnosing retained products of conception (RPOC) are still lacking.

    Diagnostic criteria for retained products of conception—A scoping review · 2021 · DOI

  • We tried to conduct comprehensive electronic database search but, we cannot rule out that we might have missed some relevant articles or unpublished data. Most studies did not evaluate AEs as study outcome assessment. It may be because the occurrence of AEs was indeed too rare or because awareness of the AEs was actually too low, as in the CM review. There were no RCTs, and all studies are case reports and case series without controls that were retrospectively studied. The sample sizes of the studies were very small. To detect teratogenicity, a large epidemiological study firm conclusion of the is needed. Therefore, we could not draw a safety of KHM during pregnancy. More studies with rigorous designs to assess the safety are needed. Please cite this article in press as: J. Jo, et al., Use and safety of Korean herbal medicine during pregnancy: A Korean medicine literature review, Eur. J. Integr. Med.

    Use and safety of Korean herbal medicine during pregnancy: A Korean medicine literature review · 2016 · DOI

  • There is no consensus on the optimal treatment for AV in pregnant or non-pregnant women, but a broader spectrum drug such as clindamycin is preferred above metronidazole to prevent infection-related preterm birth.

    Aerobic vaginitis in pregnancy · 2011 · DOI

  • " CONCLUSIONS: This review highlights four research gaps in the literature, a lack of: large representative samples; in-depth understanding of user experiences and risk perceptions; research comparing consumption patterns across cultures and over time; and work exploring the nature of the therapeutic encounter with complementary practitioners in this area of women's health care.

    Women's Use of Complementary and Alternative Medicine During Pregnancy: A Critical Review of the Literature · 2009 · DOI

  • Little is known concerning possible hazards of maternal use of the recently introduced antidepressant drugs with noradrenergic and varying serotonergic activity (serotonin-noradrenaline reuptake inhibitor [SNRI]/noradrenergic reuptake inhibitor [NRI] drugs).

    Delivery Outcome in Relation to Maternal Use of Some Recently Introduced Antidepressants · 2007 · DOI

  • Chronic inflammatory barrier diseases (CIBDs) affect many women of reproductive age, yet the safety of biologics during pregnancy remains inadequately investigated.

    Risk of Adverse Pregnancy Outcomes in Patients with Non-Communicable, Chronic Inflammatory Barrier Diseases Under Systemic Treatment: A Large-Scale Retrospective Cohort Study · 2026 · DOI

  • Larger, adequately powered, prospectively registered multicenter randomized controlled trials with comprehensive safety surveillance and long- term neonatal follow-up are warranted before pravastatin can be confidently recommended as a preventive therapy for preterm birth.

    Pravastatin for Prevention of Preterm Birth in High-Risk Pregnancies: A Pilot Randomized Controlled Trial · 2026 · DOI

  • This upstream reduction in disease severity, combined with improved gestational prolongation, translated into more favorable perinatal outcomes, suggesting potential broad clinical implications that warrant further investigation in larger trials.

    Pravastatin for Prevention of Preterm Birth in High-Risk Pregnancies: A Pilot Randomized Controlled Trial · 2026 · DOI

  • However, evidence regarding the risks of PB or CA remains inconclusive, as no statistically significant associations were observed.

    Birth outcomes associated with maternal antiglaucoma medication exposure: a systematic review and meta-analysis · 2026 · DOI

  • Peripheral neuropathy related to thiamine deficiency in pregnancy remains a rare and likely underrecognized condition, particularly in women with prolonged vomiting and poor nutritional intake.

    Dry Beriberi During Pregnancy After Hyperemesis Gravidarum: A Case Report of Axonal Sensorimotor Polyneuropathy · 2026 · DOI

  • In September, the United States Task Force on Research Specific to Pregnant Women and Lactating Women issued its advice to the secretary of Health and Human Services on addressing gaps in knowledge and research on safe and effective therapies for pregnant women and lactating women.

    Pregnant Women Can Finally Expect Better · 2019 · DOI

  • However, the current sample size is insufficient for definitive conclusions, and ribavirin exposure should be avoided during pregnancy and during the 6 months prior to pregnancy, in accordance with prescribing information.

    The Ribavirin Pregnancy Registry: An Interim Analysis of Potential Teratogenicity at the Mid-Point of Enrollment · 2017 · DOI

  • Conclusions This naturalistic study adds to the limited literature about treatment with atypical antipsychotic agents in pregnancy, though not adequately powered to detect small differences in malformations or obstetrical outcomes.

    Atypical antipsychotic use and outcomes in an urban maternal mental health service · 2016 · DOI

  • Second-generation antipsychotics (SGAs) are increasingly used for a variety of mental illnesses; however, the data regarding the safety of these medications during pregnancy are inconclusive and contradictory.

    Pregnancy Outcomes Following In Utero Exposure to Second-Generation Antipsychotics · 2015 · DOI

  • This is not unlike other female medical conditions that have been underinvestigated, and perhaps as a result, erroneous assumptions about them persist.

    Women's Experiences with a Pregnancy Complication · 2002 · DOI

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41 open questions have been extracted from the limitations and future-work passages of 705 Pregnancy and Medication Impact papers in our library. Each one below links back to the study that raised it, so you can read the original claim in context.

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