METHODS: MEDLINE, EMBASE, PubMed, Cochrane Controlled Trials Register, Web of Science, ProQuest, and the WHO Clinical Trials Registry were searched. Studies were included if they randomized adults with orthostatic hypotension to droxidopa or to control, and outcomes related to symptoms, daily activity, blood pressure, or adverse events. Data were extracted independently by two reviewers. Risk of bias was judged against the Cochrane risk of bias tool and quality of evidence measured using Grading of Recommendations Assessment, Development and Evaluation criteria. A fixed-effects model was used for pooled analysis.
RESULTS: Of 224 identified records, four studies met eligibility, with a pooled sample size of 494. Study duration was between 1 and 8 weeks. Droxidopa was effective at reducing dizziness [mean difference -0.97 (95% confidence interval -1.51, -0.42)], overall symptoms [-0.52 (-0.98, -0.06)] and difficulty with activity [-0.86 (-1.34, -0.38)]. Droxidopa was also effective at improving standing SBP [3.9 (0.1, 7.69)]. Rates of adverse events were similar between droxidopa and control groups, including supine hypertension [odds ratio 1.93 (0.87, 4.25)].
CONCLUSION: Droxidopa is well tolerated and effective at reducing the symptoms associated with neurogenic orthostatic hypotension without increasing the risk of supine hypertension.
REGISTRATION: PROSPERO ID CRD42015024612.
METHODOLOGY: This prospective, randomized, controlled trial enrolled pregnant females undergoing LSCS after spinal anesthesia. The participants were randomized into two groups: a novel 3D device group and a traditional wedge group. Primary outcome measures included the incidence of SHS, while secondary outcomes included maternal hemodynamic parameters, fetal outcomes, feasibility, ease of use, and the safety profile of the devices.
RESULTS: Baseline characteristics were well balanced between the two groups. Although some differences in maternal hemodynamic parameters were noted, the incidence of SHS was significantly lower in the novel 3D device group than that in the traditional wedge group. Fetal outcomes did not differ significantly between the groups. The novel 3D device demonstrated high compatibility with various patient anatomies and was easy to integrate into routine practice. The adverse event profiles were similar between the groups.
CONCLUSION: This study highlights the potential of a novel 3D-printed uterine displacement device for preventing SHS during LSCS, thereby improving maternal and fetal outcomes. Future research should further validate these findings and explore the long-term implications of the maternal and neonatal outcomes.