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Completed

NCT Number: NCT05858775

Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation

The assessment of cervical stiffness plays a major role in obstetrics, for example to assess the risk of preterm birth.

The Pregnolia System is a CE-certified measuring device that objectively determines cervical stiffness using a slight negative pressure. The Pregnolia System was developed in Switzerland and resulted from a research project of the ETH and the University Hospital Zurich.

Until now, the stiffness of the cervix was examined and individually assessed by palpation (palpation with fingers). The Pregnolia System was developed to make this measurement objective and independent of the examining person.

The aim of the study is to measure cervical stiffness at different locations on the cervix to see if there are differences between the measurement locations.

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Key information

Conditions

Cervix; Pregnancy

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

gynosense AG, Uster, Switzerland

Loading trial locations.

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 at GA 16+0 - 22+6
  • Singleton pregnancy
  • 18 years or older
  • Nulliparous cohort: nulliparous pregnant woman
  • Multiparous cohort: multiparous pregnant woman

Exclusion criteria

  • Lack of informed consent
  • Placenta praevia
  • Severe vaginal bleeding
  • Rupture of membranes before 34 weeks (to be excluded with pH test)
  • Visible tissue scarring at the measurement locations* 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
  • Vaginal or cervical infections (to be excluded with the Amsel criteria)

Treatment and study plan

Pregnolia System

Device

Cervical stiffness assessment with the Pregnolia System at 3 locations on the uterine cervix.

Primary outcomes

  1. Cervical Stiffness Index at 16+0 - 22+6

    Time frame: 16+0 - 22+6 gestational weeks

    Cervical Stiffness Index (CSI, in mbar) measured at 3 locations on the cervix (approximately 12, 4 and 8 o'clock, in a random order) at mid-pregnancy (16+0 - 22+6 gestational weeks).

Secondary outcomes

  1. Cervical Stiffness Index (repetition)

    Time frame: 16+0 - 22+6 gestational weeks and optional follow-up visits

    Cervical Stiffness Index (CSI, in mbar) measured 3 times at each location

  2. Cervical Stiffness Index (cohort)

    Time frame: 16+0 - 22+6 gestational weeks and optional follow-up visits

    Cervical Stiffness Index (CSI, in mbar) for each cohort.

  3. Delivery data

    Time frame: 1-4 weeks after delivery or termination of the pregnancy

    Delivery data

Sponsors and collaborators

Lead sponsor

Pregnolia AG

Industry

Registry information

Official study title

MAPVIX: Mapping the Uterine Cervix Stiffness of Pregnant Women at Mid Gestation

Acronym: MAPVIX

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 15, 2023
Registry last updated
Feb 5, 2026

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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