An Insider’s Guide to Challenges in Conducting a Randomized Controlled Trial in an Obstetric Unit Especially of a Developing Country


The hallmark of a randomized controlled trial is the low possibility of bias and its ability to provide results as close to the truth. If one intervention is found to be statistically superior, the same result can be reproduced 95 times of the 100 times the study is repeated. The challenge, however, is in executing the study without bias with the appropriate and feasible sample size to detect a statistically significant difference in the outcomes of the two arms of the study. In randomized controlled trials, obtaining the consent of participants, after informing them that they will not have a choice as to which group they will be allocated, is important. This is particularly important when research is being conducted in a developing country where there is paucity of information on research participation. The benefits and importance of research is not widely known among our women. The research question in the published research “Digital Stretching of Cervix in the Active Phase of Labour to Shorten Its Duration: A Randomised Control Trial” Rosario et al. evolved from an unanswered practical problem that had to be tackled in day-to-day obstetric practice. The research team formulated a randomized controlled trial to answer this research question. We chose this design as we were testing the efficacy of an intervention. The most important outcome called the primary outcome is carefully identified and a hypothesis stated. At the end of the research, this hypothesis is either confirmed or rejected. The prevalence of primary outcome from previous research or pilot studies is used to calculate the sample size. The major challenge in executing a randomized controlled trial in an obstetric unit of a developing country is finding time amid the hectic clinical schedule. Funding opportunities are minimal for small research in a developing country and careful implementation of study with the available resources is important.

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