Ethical challenges posed by clinical trials in preterm labor: a case study

Sofía P Salas

doi:10.1186/s12978-017-0427-x

Abstract

This paper explores the ethical implications of a randomized double-blind clinical trial aimed to determine effectiveness and safety of an oxytocin receptor antagonist versus a betamimetic in the treatment of preterm labor, presented to a teaching hospital affiliated with a private university in Santiago, Chile. Though this trial protocol fulfills one of the conditions under which pregnant women could be enrolled in a clinical trial—the intervention has the potential to benefit the pregnant woman (by reducing adverse effects associated to salbutamol administration) and her fetus (if the new drug prolongs pregnancy)—there are some specific ethical issues raised. First, when to obtain consent is an important issue for clinical trials involving acute and unforeseen conditions that affect pregnant woman, e.g. preterm labor. Second, research must address the risk/benefit ratio for these two interdependent individuals, providing a good prospect of low risk and adequate benefit for both of them. Thirdly, specifically when a study is sponsored by a high-income country and conducted in a low- or middle-income country, decisions regarding ancillary care provisions for research participants should be made in advance. Lastly, researchers must consider the requirements for paternal consent based on cultural contexts.

Highlights

Preterm birth, defined as birth occurring between 20 and 36 weeks of gestation, is a major cause of perinatal morbidity and mortality
A study design aimed to compare effectiveness and safety of the oxytocin receptor antagonist versus a betamimetic in the treatment of preterm labor was presented at the institutional review board (IRB) of a teaching hospital affiliated with a private university in Correspondence: sofia.salas@udp.cl Program of Ethics and Public Policies in Human Reproduction, Faculty of Medicine, Universidad Diego Portales, Santiago, Chile
We focus on the specific ethical issues raised by clinical trials conducted with pregnant women experiencing preterm labor

Summary

Introduction

Preterm birth, defined as birth occurring between 20 and 36 weeks of gestation, is a major cause of perinatal morbidity and mortality. Preterm complications are the leading cause of death among children under the age of five, and in low-income settings, nearly half of births occurring before 32 weeks of gestation result in death due to lack of cost-effective care [1, 2]. In 1999, when this study protocol was submitted, there was no clear evidence on which tocolytic drug was preferable. The most frequently used tocolytic agents were beta-adrenergic agonists (betamimetics), maternal side effects—cardiovascular adverse events are reported in nearly 80% of the women—usually caused early discontinuation of the therapy despite its effectiveness in delaying birth for more than 48 h [1, 3, 4]

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Conclusion