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Completed

NCT Number: NCT05200117

Pregnolia System Intra-observer Variability

The Pregnolia System is a CE-marked medical device assessing the mechanical stiffness of cervical tissue in women. The Pregnolia Probe has been engineered to minimize the influence of differences in handling and technique by the user.

This project aims to study intra-observer variability of the Pregnolia System in pregnant women in the clinical setting.

Furthermore, a same day repeated measurement serves to investigate the time period needed to recover the pre-measurement stiffness state due to viscoelasticity of the cervical tissue.

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Key information

Conditions

Cervix; Pregnancy Cervical Stiffness

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Kantonsspital Frauenfeld

Frauenfeld, 8501, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Informed Consent signed by the subject
  • Pregnant woman
  • Singleton pregnancy
  • 18 years or older
  • Nulliparous cohort: nulliparous pregnant woman
  • Multiparous cohort: multiparous pregnant woman

Exclusion criteria

  • Lack of informed consent
  • Placenta praevia totalis with haemorrhage (irrespective of severity)
  • Severe vaginal bleeding
  • Rupture of membranes before 34 weeks (to be excluded with pH test)
  • Visible tissue scarring at 12 o'clock position on cervix
  • Light bleeding (if the bleeding can be stopped, it is no longer an exclusion criterion)
  • Cervical dilation ≥ 3 cm
  • Cerclage or pessary in place

Treatment and study plan

Pregnolia System

Device

The cervical stiffness is measured with the Pregnolia System three times over a two-day period.

Primary outcomes

  1. Cervical Stiffness Index

    Time frame: Measurements between 14+0 and 41+6 weeks gestational weeks

    Cervical Stiffness Index (CSI, in mbar) measured repeatedly after 2 to 4 hours and approximately 24 hours at three different locations on the uterine cervix.

Secondary outcomes

  1. Cervical Stiffness Index (CSI, in mbar)

    Time frame: Measurements between 14+0 and 41+6 weeks gestational weeks

  2. Elapsed time between

    Time frame: Measurements between 14+0 and 41+6 weeks gestational weeks

    The elapsed time between when the subject got out of bed until the measurements were taken

  3. Device-related adverse events

    Time frame: Measurements between 14+0 and 41+6 weeks gestational weeks

    Device-related adverse events (incidence, severity, and seriousness)

Sponsors and collaborators

Lead sponsor

Pregnolia AG

Industry

Registry information

Official study title

Intra-observer Variability in the Assessment of Cervical Stiffness With the Pregnolia System

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 20, 2022
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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