Ethical Issues in Pharmacologic Research in Women Undergoing Pregnancy Termination: A Systemic Review and Survey of Researchers

Gedeon, C.; Nava-Ocampo, Alejandro A; Koren, Gideon

doi:10.1155/2012/724591

Cited by 6 publications

(3 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Aborted fetuses from women undergoing pregnancy termination have been recruited to determine the neuroendocrinological alterations caused by maternal diseases or over-the-counter (OTC) and prescription drug administrations during pregnancy worldwide since 1973 [91]. However, a survey in 2012 revealed the fact that this kind of research is not likely to be approved by most North American medical institutions for ethical considerations [92]. Moreover, assessing fetal exposure effect is limited to a single cord plasma concentration measured at the time of delivery, i.e., real-time monitoring of fetal neuroendocrine profile is not allowed.…”

Section: Ethical Issues In Human and Rodent Researchmentioning

confidence: 99%

Gestational Tryptophan Fluctuation Underlying Ontogenetic Origin of Neuropsychiatric Disorders

Huang¹,

Li²,

Cheng³

2023

Cognitive Behavioral Therapy - Basic Principles and Application Areas

View full text Add to dashboard Cite

Neuropsychiatry underlies personality development and social functioning. Borderline personality disorder exhibits high trait aggression and is associated with tryptophan hydroxylase polymorphisms. The acute tryptophan depletion reduces plasma and cerebrospinal fluid tryptophan availability and brain serotonin concentrations, leading to alterations in personality and trait-related behaviors. Tryptophan is essential for fatal neurodevelopment and immunomodulation in pregnancy. Gestational tryptophan fluctuation induced by maternal metabolic disorders or drug administrations may account for the maternal-fetal transmission determining neurogenesis and microbial development, consequentially shaping the long-standing patterns of thinking and behavior. However, it is not possible to assess the gestational tryptophan exposure effects on fetal brain and gastrointestinal system in humans for ethical reasons. The maternal–fetal microbe transmission in rodents during gestation, vaginal delivery, and breastfeeding is inevitable. Chicken embryo may be an alternative and evidence from the chicken embryo model reveals that gestational tryptophan fluctuation, i.e., exposed to excessive tryptophan or its metabolite, serotonin, attenuates aggressiveness and affects peer sociometric status. This chapter discusses the gestational tryptophan fluctuation as a risk factor of personality disorders in offspring and the prevention of personality disorders by dietary tryptophan control and medication therapy management during pregnancy.

show abstract

Section: Ethical Issues In Human and Rodent Researchmentioning

confidence: 99%

Gestational Tryptophan Fluctuation Underlying Ontogenetic Origin of Neuropsychiatric Disorders

Huang¹,

Li²,

Cheng³

2023

Cognitive Behavioral Therapy - Basic Principles and Application Areas

View full text Add to dashboard Cite

show abstract

“…As ethical issues complicate the study of pharmacological safety, attention is drawn to the few clinical studies conducted in the last 40 years involving women with termination of pregnancy, which are concentrated on analyzing drug absorption and distribution in aborted fetuses. Only 5 works (23.8%) were conducted in the 2000s [17]. Due to the lack of ethical rules for such studies, they are primarily conducted outside of North America.…”

Section: Use Of Omics Technologies In Obstetricsmentioning

confidence: 99%

“…Due to the lack of ethical rules for such studies, they are primarily conducted outside of North America. However, polls of both specialists (researchers and attending physicians) and women themselves confirm reasonability of such studies [17,18]. The population of the patients, who had suffered abortion, may also serve as a relevant pharmacological group and used as an analyzed population regarding study of gestational use of drugs without risk of any undesirable consequences for fetuses.…”

Section: Use Of Omics Technologies In Obstetricsmentioning

confidence: 99%

Modern Paradigm of the Pregnant-Involving Pharmacological Study: Risk Assessment, Ethical Principles and Regulatory Aspect

Александрович¹,

Reshetko²,

Луцевич³

2014

Pediatr. farmakol.

View full text Add to dashboard Cite

Clinical practice indicates that the lack of evidence database on the effect of drugs and biological products on the course of pregnancy presents women and doctors in charge with a difficult dilemma, when prescription of the drugs, which have not undergone clinical studies, renders correct dosage and account of potential fetus-associated effects impossible. On the other hand, refusal to use drugs during pregnancy may result in harm to health not only of mothers, but also of their unborn r newborn children caused by the disease-associated pathological alterations [1,2]. Risk/benefit balance of drug therapy is not always clear both for a mother and her fetus; it is circumstantial and specific in every woman [3]. In order to minimize embryofetal risk, it is necessary to identify and avoid using nonessential drugs, regulate dose, frequency and way of administration of the drug and duration of the essential treatment. It ought to be mentioned, though, that development of new drugs for treating pregnancy-associated pathological conditions present scientists with the challenges that only rarely occur in other populations. Any drug interventions awake in women fear of pregnancy-and labor-associated complications. This fact complicates clinical studies of drugs, because any risk assumption renders such clinical studies unacceptable for pregnant women. On the other hand, there is an obvious need in validating drug efficacy and safety data obtained in the clinical studies involving different populations of patients with respect to pregnant women, as their bodies undergo a range of functional changes during gestation [4]. Additional studies aimed at identifying the factors determining pregnancy-associated changes of pharmacokinetics (PK) and pharmacodynamics (PD) of drugs are required for women not to be barred from achievements of the modern pharmacotherapy. There is also an ethical dilemma of involving this particularly sensitive category of patients in randomized controlled studies of safe and efficacy of drugs [5]. At the same time, new discipline -obstetric-fetal pharmacology -may form the basis of extensive study of gestational use of drugs [6]. In order to enable pharmacological studies involving pregnant women, a model, which

show abstract

Ethics of Studies of Drugs in Pregnancy

Matsui

2014

Pediatr Drugs

View full text Add to dashboard Cite

Pregnant women with illness require efficacious and safe drug therapy during pregnancy; however, their treatment is often hindered by a lack of information regarding the use of medications during pregnancy. Ethical challenges are encountered in conducting drug trials in pregnant women, who are often excluded from participation due to fear of harm to the fetus. However, as the health of the fetus is ultimately affected by that of the pregnant woman, inclusion of pregnant women in studies of medications that they may require for their own benefit may also benefit the unborn child. The principle of autonomy argues for the pregnant woman being able to make an informed choice to take part in a clinical trial, and the principle of justice dictates that she not be denied the benefits of drug research.

show abstract

Ethical Issues in Pharmacologic Research in Women Undergoing Pregnancy Termination: A Systemic Review and Survey of Researchers

Cited by 6 publications

References 23 publications

Gestational Tryptophan Fluctuation Underlying Ontogenetic Origin of Neuropsychiatric Disorders

Gestational Tryptophan Fluctuation Underlying Ontogenetic Origin of Neuropsychiatric Disorders

Modern Paradigm of the Pregnant-Involving Pharmacological Study: Risk Assessment, Ethical Principles and Regulatory Aspect

Ethics of Studies of Drugs in Pregnancy

Contact Info

Product

Resources

About