ReviewBritish journal of clinical pharmacology2018
Inclusion of pregnant and breastfeeding women in research - efforts and initiatives.
Review in British journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 43 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
43 citing papers in PubMed, 1 synthesis or guideline pooled it, 73 citations in OpenAlex.
- Pooled it
- Article
- A Phase 1 Multiple-Dose, Open-Label, Pharmacokinetic Study of Nirmatrelvir/Ritonavir in Healthy Lactating Women.Clinical and translational science · 2026Article
- Bridging disciplinary siloes: a scoping review on the inclusion and exclusion of pregnant and lactating populations in clinical research.BMJ public health · 2026Article
- Medicine use during breastfeeding in Uganda: stakeholder perspectives on barriers and facilitators.International breastfeeding journal · 2025Article
- Recent advances in alcohol metabolism: from the gut to the brain.Physiological reviews · 2025Review
- EudraVigilance insights: Suspected adverse drug reactions in infants through breastfeeding.British journal of clinical pharmacology · 2025Observational
- Population Pharmacokinetic Modeling of Amoxicillin in Plasma and Milk in Lactating Göttingen Minipigs - A Contribution from the ConcePTION Project.The AAPS journal · 2025Article
- How can we advance drug delivery options using extracellular vesicles for pregnant women to reduce preterm birth?Expert opinion on drug delivery · 2025Article
- Clinical lactation studies. Acting on key recommendations over the last decade.npj women's health · 2025Review
- Pragmatic and contextualized methods selection for safety assessment of infant systemic exposure through human milk: the Milk4baby decision tree approach - a contribution from the concePTION project.Frontiers in pharmacology · 2025Article
- Modeling reproductive and pregnancy-associated tissues using organ-on-chip platforms: challenges, limitations, and the high throughput data frontier.Frontiers in bioengineering and biotechnology · 2025Review
- Adverse Drug Reactions in Pregnant People with Hypertension and/or Diabetes: Temporal Profile and Associated Factors.The Canadian journal of hospital pharmacy · 2025Article
- Maternal-Child Human Immunodeficiency Virus Clinical Trials Networks across the Ages.Clinics in perinatology · 2024Review
- Addressing health equity for breastfeeding women: primaquine for Plasmodium vivax radical cure.Malaria journal · 2024Review
- New approach methods on the bench side to accelerate clinical trials during pregnancy.Expert opinion on drug metabolism & toxicology · 2024Review
- Trying to get breastfeeding women out of the pharmaceutical orphanage.Pediatric research · 2024Article
- Predicting Maternal and Infant Tetrahydrocannabinol Exposure in Lactating Cannabis Users: A Physiologically Based Pharmacokinetic Modeling Approach.Pharmaceutics · 2023Article
- Evaluating the Pharmacokinetics of Fentanyl in the Brain Extracellular Fluid, Saliva, Urine, and Plasma of Newborns from Transplacental Exposure from Parturient Mothers Dosed with Epidural Fentanyl Utilizing PBPK Modeling.European journal of drug metabolism and pharmacokinetics · 2023Article
- The Analysis of Pethidine Pharmacokinetics in Newborn Saliva, Plasma, and Brain Extracellular Fluid After Prenatal Intrauterine Exposure from Pregnant Mothers Receiving Intramuscular Dose Using PBPK Modeling.European journal of drug metabolism and pharmacokinetics · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Pregnant and breastfeeding women have been rendered therapeutic orphans as they have been historically excluded from clinical trials. Labelling for most approved drugs does not provide information about safety and efficacy during pregnancy. This lack of data is mainly due to ethico-legal challenges that have remained entrenched in the post-diethylstilbestrol and thalidomide era, and that have led to pregnancy being viewed in the clinical trial setting primarily through a pharmacovigilance lens. Policy considerations that encourage and/or require the inclusion of pregnant or lactating women in clinical trials may address the current lack of available information. However, there are additional pragmatic strategies, such the employment of pharmacometric tools and the introduction of innovative clinical trial designs, which could improve knowledge about the safety and efficacy of medication use during pregnancy and lactation. This paper provides a broad overview of the pharmacoepidemiology of drugs used during pregnancy and lactation, and offers recommendations for regulators and researchers in academia and industry to increase the available pharmacokinetic and -dynamic understanding of medication use in pregnancy.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.