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Search / Trial NCT05200117

Pregnolia System Intra-observer Variability

Launched by PREGNOLIA AG · Jan 6, 2022

Trial Information

Current as of June 30, 2025

Completed

Keywords

Cervical Stiffness Intra Observer Variability Pregnolia System Cervical Stiffness Index Csi Stiffness Measurement

ClinConnect Summary

No description provided

Gender

FEMALE

Eligibility criteria

  • 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

About Pregnolia Ag

Pregnolia AG is an innovative clinical trial sponsor focused on advancing women's health, particularly in the areas of pregnancy and reproductive medicine. With a commitment to developing cutting-edge solutions, Pregnolia AG leverages its expertise in medical technology and clinical research to address critical challenges in maternal and fetal health. The company aims to enhance clinical outcomes through the development of novel diagnostic and therapeutic approaches, ensuring the safety and well-being of both mothers and their children. By collaborating with leading healthcare professionals and institutions, Pregnolia AG strives to contribute significantly to the field of obstetrics and gynecology.

Locations

Frauenfeld, , Switzerland

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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