Enrolling Pregnant Women in Research — Lessons from the H1N1 Influenza Pandemic

Goldkind, Sara F.; Şahin, Leyla; Gallauresi, Beverly Albrecht

doi:10.1056/nejmp1003462

Cited by 76 publications

(65 citation statements)

References 5 publications

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“…Moreover, such studies help to find optimal ways of studying other vulnerable populations, such as pregnant women. It has been recommended to develop and adopt the same legislation for pregnant women as for children if there are no other ways to involve them in pharmacological studies as research subjects [19]. Peculiarities of assessing drug vulnerability risk in pregnant women.…”

Section: Approaches To Risk Evaluation Of Pregnant Women Involvement mentioning

confidence: 99%

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

Александрович¹,

Reshetko²,

Луцевич³

2014

Pediatr. farmakol.

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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

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Section: Approaches To Risk Evaluation Of Pregnant Women Involvement mentioning

confidence: 99%

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

Александрович¹,

Reshetko²,

Луцевич³

2014

Pediatr. farmakol.

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“…However, these women represent a specific MS subpopulation that may not be generalizable to the wider MS population. Nonetheless, increasingly, there has been debate about the merits of including a limited number of pregnant women in clinical trials [56]. There are some situations where the use of drug therapy during pregnancy may be justifiable.…”

Section: Potential Role Of Clinical Trialsmentioning

confidence: 99%

“…Likewise, a woman with epilepsy may be safer continuing anticonvulsants throughout pregnancy rather than risk experiencing significant hypoxic events due to seizures that could be life-threatening to her and her child [57]. When clinically justified, a smaller scale clinical trial with regular, close followup of mothers has been suggested -especially if drug therapy during pregnancy is unavoidable due to the mother's medical condition [56].…”

Section: Potential Role Of Clinical Trialsmentioning

confidence: 99%

Safety of disease-modifying drugs for multiple sclerosis in pregnancy: current challenges and future considerations for effective pharmacovigilance

Wang

Guimond

et al. 2013

Expert Review of Neurotherapeutics

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“…Preventive strategies and appropriate treatment modalities for pregnant women were among the major concerns for health services during pandemy. In high risk groups including pregnant women comprehensive treatment methods were required (5) .…”

Section: Swine Flu Caused the First Outbreak In Mexico In Aprilmentioning

confidence: 99%

Maternal and Fetal Outcomes of Pregnancies Treated for H1N1 Virus Infection

Demir¹,

Akduman²,

Okçu³

et al. 2013

J Turk Soc Obstet Gynecol

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Organization (WHO). In this study we aimed to assess the maternal and fetal outcomes of pregnant women with the diagnosis of H1N1viral infection Key words: H1N1 infection, newborn, pregnancy Journal of Turkish Society of Obstetrics and Gynecology, (J Turk Soc Obstet Gynecol), Vol: 10, Issue: 4, Pages: 220-5 H1N1 ENFEKS‹YONU NEDEN‹YLE TEDAV‹ ED‹LEN GEBELER‹N MATERNAL VE FETAL SONUÇLARI ÖZET

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Enrolling Pregnant Women in Research — Lessons from the H1N1 Influenza Pandemic

Cited by 76 publications

References 5 publications

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

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

Safety of disease-modifying drugs for multiple sclerosis in pregnancy: current challenges and future considerations for effective pharmacovigilance

Maternal and Fetal Outcomes of Pregnancies Treated for H1N1 Virus Infection

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