Measurement of cervical softness before cerclage placement with an aspiration-based device.

Background: An abnormally soft cervix could contribute to the pathophysiology of cervical shortening and cervical insufficiency. Multiple techniques to measure cervical softness have been developed but none are used routinely in clinical practice. A clinically acceptable technique to measure cervical softness could improve identification of patients at risk for cervix-related preterm birth.

Objective: This study aimed to measure cervical softness in patients with cervical insufficiency and in normal controls using a novel, aspiration-based device. We hypothesized that the cervix is softer in patients with cervical insufficiency.

Study Design: This was a cross-sectional study of patients presenting for cerclage at a single academic medical center. Cervical softness was measured using a noninvasive, aspiration-based device placed on the anterior lip of the cervix during a speculum examination. The device measured the aspiration pressure required to displace cervical tissue to a predefined deformation level. Stiff tissue required increased aspiration pressure, whereas soft tissue required lower pressure values. Cerclage patients were subdivided into 3 groups, namely history-indicated, ultrasound-indicated, and examination-indicated cerclage. Controls were healthy volunteers between 12+0 weeks and 23+6 weeks of gestation without a history of cervical insufficiency and were matched by gestational age to the patients in the cerclage groups. Women with a cerclage in place, multiple gestations, active genital infection, or previous cervical excision procedures were excluded. Delivery information was subsequently recorded as well.

Results: Data from 133 women were analyzed; of those, 54 patients were in the cerclage group (23 history-indicated, 12 ultrasound-indicated, and 19 examination-indicated participants) and 79 were controls (40 in the first trimester and 39 in the second trimester groups). Patients who presented for ultrasound-indicated cerclage had significantly softer cervices (median; interquartile range) than second trimester controls (62 mbar; 50.5-114 vs 81 mbar; 75-101; P=.042). The difference in cervical softness was not significantly different between the history-indicated and examination-indicated cerclage groups and their respective control groups.

Conclusion: Patients presenting for ultrasound-indicated cerclage had significantly softer cervices than normal controls as measured by an aspiration-based device. Quantitative measurement of cervical softness with the aspiration-based device is a promising technique for objective measurement of cervical softness during pregnancy.