Trials
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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
Pipelle for Pregnancy (PIP): study protocols for three randomised controlled trials.
The success rate of infertility treatments remains modest. Endometrial injury has been suggested as an intervention to increase the probability of pregnancy in women undergoing assisted reproductive technologies such as in vitro fertilisation (IVF). The majority of studies and systematic reviews have reported that endometrial injury improves the outcomes of IVF, intrauterine insemination and natural conception; however, the size and quality of the studies are poor. The low quality of the available evidence questions the presence of any real beneficial effect, and the applicability of the intervention in different populations remains unclear. ⋯ The PIP trials are designed to address the gaps in the utility of endometrial scratching as a treatment for subfertility in three different populations. If the beneficial effect of this intervention can be confirmed in these settings, endometrial scratching will provide a cost-effective method for helping women and couples to conceive.
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Randomized Controlled Trial Multicenter Study Comparative Study Pragmatic Clinical Trial
Intravenous versus epidural analgesia to reduce the incidence of gastrointestinal complications after elective pancreatoduodenectomy (the PAKMAN trial, DRKS 00007784): study protocol for a randomized controlled trial.
Despite substantial improvements in surgical and anesthesiological practices leading to decreased mortality of less than 5 % at high-volume centers, pancreatic surgery is still associated with high morbidity rates of up to 50 %. Attention is increasingly directed toward the optimization of perioperative management to reduce complications and enhance postoperative recovery. Currently, two different strategies for postoperative pain management after pancreatoduodenectomy are being routinely used: patient-controlled intravenous analgesia and thoracic epidural analgesia. Evidence is lacking to assess which strategy entails fewer postoperative complications. ⋯ Several previous studies investigating the two different strategies for postoperative pain management have mainly focused on their effectiveness in pain control. However, the PAKMAN trial is the first to compare them with regard to their impact on the surgical endpoint "postoperative gastrointestinal complications" after pancreatoduodenectomy.
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Randomized Controlled Trial Multicenter Study
Recruiting and consenting into a peripartum trial in an emergency setting: a qualitative study of the experiences and views of women and healthcare professionals.
Recruiting and consenting women to peripartum trials can be challenging as the women concerned may be anxious, in pain, and exhausted; there may also be limited time for discussion and decision-making to occur. To address these potential difficulties, we undertook a qualitative evaluation of the internal pilot of a trial (Got-it) involving women who had a retained placenta (RP). We explored the experiences and views of women and staff about the information and consent pathway used within the pilot, in order to provide recommendations for use in future peripartum trials involving recruitment in emergency situations. ⋯ By drawing upon the perspectives of women and staff involved in the same trial we have shown that they may operate within different experiential and ethical paradigms. In doing so, we argue for the potential benefits of drawing upon multiple perspectives when developing information and consent pathways used in future (peripartum) trials.