Can Cervical Stiffness in the Second Trimester Predict Preterm Birth in High-Risk Singleton Pregnancies?

The cervical stiffness is assessed by using the licensed, CE-marked Pregnolia System, during a sterile speculum examination. The single-use, sterile Pregnolia Probe is placed on the anterior lip of the cervix at 12 o'clock position and a recording of cervical stiffness is generated over maximum 60 seconds (typically ̴15 seconds) and displayed as Cervical Stiffness Index (CSI) in mbar. The measurement is repeated 3 consecutive times without any time lag.

Cervical length measurement will be obtained via transvaginal ultrasound using a GE Voluson E10 ultrasound machine and 7.5MHz transvaginal probe. All measurements will be performed with the woman in a supine position with an empty bladder in the sagittal plane measuring from the internal to external cervical OS. The full length of the cervical canal will be visualized with the closed portion of cervix remaining being measured. Three measurements are taken with the shortest being documented as the final assessment.

Vaginal swab collection. The specimen will be obtained from the posterior fornix over 10 seconds using the polyester tipped swab provided in the Hologic specimen collection kit. This sample will be then be stored frozen and processed using the Rapid fFN 10Q System (HOLOGIC, Marlborough, MA, USA) within 3 months.