Objective Cervical Stiffness Assessment Using the Pregnolia System Prior to Induction of Labour: The CASPAR...

Area of Science:

• Obstetrics and Gynecology
• Reproductive Medicine
• Clinical Trial Design

Background:

• Induction of labor (IOL) is a common obstetric procedure.
• Accurate assessment of cervical stiffness (CS) is crucial for predicting IOL success.
• The Pregnolia System (PS) offers a novel method for CS assessment.

Purpose of the Study:

• To evaluate the feasibility of the Pregnolia System (PS) for cervical stiffness (CS) assessment in women undergoing induction of labor (IOL).
• To gather data to inform the design of future studies investigating IOL outcome prediction using the PS.

Main Methods:

• A single-centre, prospective, observational feasibility study.
• 100 nulliparous women undergoing IOL at Liverpool Women's Hospital were recruited.
• Cervical stiffness was assessed using the PS and Bishop Score (BS) prior to IOL; acceptability was surveyed.

Main Results:

• Recruitment rate was 68%, indicating good feasibility.
• The PS demonstrated excellent internal consistency (Cronbach's Alpha 0.967) and lower participant discomfort than the BS.
• Both PS and BS showed poor diagnostic capability for predicting vaginal delivery after IOL.

Conclusions:

• The Pregnolia System (PS) is feasible for pre-induction cervical assessment in an IOL cohort.
• The study design, focused on feasibility, limited the ability to determine the clinical utility of the PS for predicting IOL outcomes.