The acceptability of cervical electrical impedance spectroscopy within a multi-modal preterm birth screening package:...

Area of Science:

• Obstetrics and Gynecology
• Medical Devices
• Biomedical Engineering

Background:

• Preterm birth remains a significant global health challenge, with current screening methods offering limited predictive accuracy.
• Cervical electrical impedance spectroscopy (EIS) is an emerging technique for assessing cervical ripening, a key predictor of labor onset.
• Previous studies indicate EIS's potential for accurate preterm birth prediction in asymptomatic women during mid-pregnancy.

Purpose of the Study:

• To evaluate the acceptability of cervical EIS as a screening tool for preterm birth among low and high-risk pregnant women.
• To assess women's experiences, including anxiety, pain, and overall satisfaction, with cervical EIS within a larger prospective trial.
• To gather insights for refining EIS screening protocols and device design for broader clinical implementation.

Main Methods:

• A parallel convergent mixed-methods study involving 40 women undergoing screening tests (EIS, cervical length, fetal fibronectin).
• Quantitative data collected via questionnaires on anxiety (STAI-6), pain (McGill Pain Questionnaire), and acceptability (visual analogue scales).
• Qualitative data gathered through semi-structured interviews with 21 women (11 high-risk, 10 low-risk), followed by thematic analysis and data triangulation.

Main Results:

• High-risk women experienced a significant reduction in anxiety post-screening (mean STAI-6: 34.5 to 29.0, p=0.002), with a similar trend in low-risk participants.
• Pain ratings were consistently low across all participants (mean VAS 0.97-1.01), comparable to conventional screening methods.
• Qualitative findings highlighted the influence of device design, prior experiences, and staff interaction on the overall screening experience and acceptability.

Conclusions:

• Cervical EIS is a well-tolerated and acceptable method for preterm birth screening in both low and high-risk women when integrated into a multi-modal approach.
• The study provides crucial data to inform the development of future cervical EIS screening protocols and study designs.
• Findings underscore the importance of considering patient experience, device design, and clinical interaction for successful implementation of novel screening technologies.