Search

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. [ABSTRACT FROM AUTHOR]

Background: Maternal death reviews and obstetric audits identify causes and circumstances related to occurrence of a maternal death or serious complication and inform improvements in quality of care. Given Nigeria's high maternal mortality, the lessons learned from past experiences can provide a good evidence base for informed decision making. We aimed to synthesise findings from maternal death reviews and other obstetric audits conducted in Nigeria through a systematic review, seeking to identify common barriers and enabling factors related to the provision of emergency obstetric care. Methods: We searched for maternal death reviews and obstetric care audits reported in the published literature from 2000-2014. A 'best-fit' framework approach was used to extract data using a structured data extraction form. The articles that met the inclusion criteria were assessed using a nine point quality score. Results: Of the 1,841 abstracts and titles at initial screening, 329 full text articles were reviewed and 43 papers fulfilled the inclusion criteria. Four types of barriers were reported related to: transport and referral; health workers; availability of services; and organisational factors. Three elements stand out in Nigeria as contributing to maternal mortality: delays in Caesarean section, unavailability of magnesium sulphate and lack of safe blood transfusion services. Conclusions: Obstetric care reviews and audits are useful activities to undertake and should be promoted by improving the processes used to conduct them, as well as extending their implementation to rural and basic level health facilities and to the community. Urgent areas for quality improvement in obstetric care, even in tertiary and teaching hospitals should focus on organisational factors to reduce delays in conducting Caesarean section and making blood and magnesium sulphate available for all who need these interventions. [ABSTRACT FROM AUTHOR]