postpartum hemorrhage, maternal mortality, high-risk pregnant women, randomized double-blind clinical trial, informed consent, return of findings
Postpartum hemorrhage (PPH) is a largely preventable maternal condition that is managed medically in developed countries. However, mortality from PPH remains high in developing countries, accounting for up to 60% of all maternal deaths annually. Based on published studies on the clinical efficacy of two drugs commonly used to treat PPH (drugs A and B) a practicing obstetrics and gynecology physician in a metropolitan hospital conducted a randomized double-blind clinical trial in high-risk pregnant women. The goal of the study was to determine which drug would lead to better treatment outcomes for PPH.
The researcher recruited pregnant women admitted to the hospital’s antenatal ward (which manages pregnancy-related complications), then randomly assigned individuals into two groups to receive either drug A or drug B right after their childbirth. Both the researcher and the patients were blind to the treatment assignments. The researcher enlisted the help of other doctors in the antenatal ward to obtain informed consent from the women to participate in the study. As a part of the routine practice, and to streamline the admissions process, the ward doctors described the PPH status of each patient and explained the potential benefits and risks of participating in the study. After the patients had given verbal consent, these doctors signed the patients’ informed consent forms as impartial witnesses. After the research was complete, data from the study revealed important information about improving the treatment of PPH in pregnant women at high risk of developing the condition.
Questions
What ethical concerns, if any, do you have with the informed consent process? What recommendations might you give to the researchers to address those concerns?
Was a randomized double-blind trial design ethically appropriate for this study? Why or why not?
Why might it be important for the researcher to share findings from the study with study participants in this scenario? What approach would you recommend to the researcher for doing so?
