A randomized comparative study to prevent supine hypotension syndrome in pregnant females undergoing LSCS after giving spinal anesthesia using a wedge and novel 3D printed uterine displacement device.

Introduction: Pregnancy induces physiological changes, including alterations in cardiovascular dynamics, predisposing pregnant women to supine hypotension syndrome (SHS) during lower-segment cesarean section (LSCS) under spinal anesthesia. Various methods, including manual displacement of the uterus and use of wedges or cushions, have been proposed to prevent SHS, but their effectiveness remains variable. This study aimed to compare the efficacy of a novel 3D-printed uterine displacement device with that of a traditional wedge in preventing SHS during LSCS after spinal anesthesia.

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.