MATERIAL AND METHODOLOGY

Source of Data

The data for this feasibility study was retrospectively collected from pregnant females undergoing lower segment cesarean sections (LSCS) at a tertiary care center. The information was derived from medical records which included intraoperative monitoring data and postoperative outcomes.

Study Design

The study was designed as a feasibility study to assess the practicality and efficacy of a novel 3D printed manual uterine displacement device during LSCS. It incorporated a randomized controlled trial format to compare outcomes between standard care practices and those augmented by the use of the 3D printed device.

Study Location

The research was conducted at the obstetrics and gynecology department of a well-equipped tertiary care hospital, which provided a conducive environment for implementing advanced surgical and monitoring techniques.

Study Duration

The study spanned a period of twelve months, from January to December 2023, allowing sufficient time to recruit participants, apply the intervention, and collect postoperative data.

Sample Size

A total of 60 pregnant females were enrolled in the study, determined by a power analysis to ensure adequate power to detect significant differences in the primary outcome measures.

Inclusion Criteria

Participants included in the study were pregnant patients scheduled for elective or emergency LSCS. The criteria focused on individuals without known comorbid conditions to minimize variability caused by underlying health issues.

Exclusion Criteria

Patients were excluded from the study if they had comorbid conditions such as cardiac disorders, pregnancy-induced hypertension (PIH), or coagulopathy. These exclusions helped to ensure that the findings were not confounded by systemic health issues that could independently affect the outcomes of interest.

Sampling Technique

The sampling technique employed was a random controlled method. Participants were randomly assigned to either the control group, which received standard care, or the intervention group, which utilized the 3D printed uterine displacement device during surgery.

Procedure and Methodology

In this feasibility study, all participants undergoing lower segment cesarean sections (LSCS) received standard care, which included routine surgical preparation and anesthesia. For those in the intervention group, a novel 3D printed manual uterine displacement device was employed. This device was specifically designed to optimally displace the uterus, thereby minimizing the pressure exerted on the inferior vena cava, which is often the cause of supine hypotension syndrome in pregnant women during surgery.

The device was manually placed by the attending obstetrician or anesthesiologist immediately after the administration of spinal anesthesia and before the surgical incision was made. The positioning of the device was adjusted to ensure maximum efficacy while maintaining patient comfort. Throughout the procedure, vital parameters such as oxygen saturation (SpO2), non-invasive blood pressure (NIBP), pulse rate (PR), and respiratory rate (RR) were continuously monitored using standard medical monitoring equipment to assess the immediate physiological impact of the device.

Additionally, the fetal outcome was evaluated immediately post-delivery using APGAR scores, which measure the baby’s appearance, pulse, grimace, activity, and respiration at 1 and 5 minutes after birth. The use of vasopressors, necessary to manage any instances of hypotension during the surgery, was meticulously documented, including the type, dosage, and timing of administration.

Sample Processing

Given the nature of the study, no biological sample processing was required. The data collected were primarily quantitative physiological measurements and observational outcomes which are standard in clinical settings, particularly in obstetric surgeries. The emphasis was placed on real-time data capture and documentation to ensure accuracy and reliability of the information gathered for later analysis.

Data Collection

Data collection was primarily observational and was carried out by the attending anesthesiologist and nursing staff, who were trained prior to the commencement of the study to ensure consistency in data recording. Standardized forms were used to document intraoperative vital signs, including SpO2, NIBP, PR, and RR. These forms also included sections for recording fetal APGAR scores and details regarding the administration of vasopressors. This method of data collection was chosen to minimize observer bias and to integrate seamlessly into the standard operating procedures of the surgical team.

Statistical Analysis

The statistical analysis of the gathered data was performed using SPSS software, a comprehensive tool that facilitates complex data manipulation and analysis. Initially, descriptive statistics such as means, standard deviations, and percentages were calculated to provide a baseline understanding of the demographic and clinical characteristics of the study population.

For inferential statistics, chi-squared tests were utilized to analyze categorical variables, primarily focusing on the incidence of supine hypotension, APGAR scores, and the necessity for vasopressors between the control and intervention groups. T-tests were used for continuous variables, such as measurements of NIBP, PR, and RR, to compare the mean differences between groups.

The significance level was set at a p-value of less than 0.05. A result below this threshold indicated that the use of the 3D printed uterine displacement device had a statistically significant effect on reducing the incidence of supine hypotension and improving overall maternal and fetal outcomes compared to the standard wedge method. This analytical approach provided a robust framework for evaluating the efficacy of the intervention and could potentially inform future clinical practices and device design considerations.

This study helps in assessing the effectiveness of a novel uterine displacement tool, specifically designed using 3D printing technology, in managing supine hypotension during cesarean deliveries under spinal anesthesia. This study addresses a crucial aspect of obstetric surgery, where maintaining maternal hemodynamic stability is essential for the safety of both mother and child.

The core objective of the research was to compare the traditional wedge method, commonly used to offset the risk of supine hypotension, with a customized 3D printed modified uterine displacement (MUD) device. The parameters compared included heart rate, systolic and diastolic blood pressure, respiratory rate, oxygen saturation, and the volume of intravenous fluids administered. Data was systematically collected at multiple time points during surgery to assess and compare the efficacy of both devices in maintaining stable physiological metrics.

The findings revealed that there were no significant differences in heart rate, respiratory rate, oxygen saturation, or intravenous fluid requirements between the two groups, indicating that the MUD device performs comparably to the traditional wedge in these aspects. However, a noteworthy observation was made regarding the diastolic blood pressure at the 10-minute post-spinal anesthesia mark, where the MUD device showed significantly better stability compared to the wedge method. This suggests a potential advantage of the MUD device in managing blood pressure shortly after anesthesia administration.

The research also highlighted the benefits of using 3D printing technology in medical device fabrication, such as customization to patient-specific needs and rapid prototyping. This technology allows for iterative design improvements based on real-time feedback from clinical use, which can enhance the functionality and user experience of medical devices in surgical settings.

Overall, this thesis supports the feasibility and effectiveness of using a novel 3D printed device for uterine displacement during cesarean sections. It adds to the growing body of literature advocating for the integration of innovative technologies in medical practice, aiming to enhance clinical outcomes and patient care in obstetrics.