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

MAPVIX: 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.

Study Overview

• Status: Recruiting
• Conditions: Cervix; Pregnancy
• Intervention / Treatment: Device: Pregnolia System

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Laura Bernardi; Phone Number: +41 44 500 84 35; Email: bernardi@pregnolia.com

Study Locations

• Switzerland
  • Uster, Switzerland
    • Recruiting
    • gynosense AG
    • Contact: Maki Kashiwagi, Dr. med.
  • Zürich, Switzerland
    • Recruiting
    • University Hospital Zürich
    • Contact: Katharina Quack Lötscher, PD Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women at gestational ages between 16+0 - 22+6 weeks

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Nulliparous cohort; Nulliparous pregnant woman	Device: Pregnolia System; Cervical stiffness assessment with the Pregnolia System at 3 locations on the uterine cervix.
Multiparous cohort; Multiparous pregnant woman	Device: Pregnolia System; Cervical stiffness assessment with the Pregnolia System at 3 locations on the uterine cervix.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical Stiffness Index at 16+0 - 22+6	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).	16+0 - 22+6 gestational weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cervical Stiffness Index (repetition)	Cervical Stiffness Index (CSI, in mbar) measured 3 times at each location	16+0 - 22+6 gestational weeks and optional follow-up visits
Cervical Stiffness Index (cohort)	Cervical Stiffness Index (CSI, in mbar) for each cohort.	16+0 - 22+6 gestational weeks and optional follow-up visits
Delivery data	Delivery data	1-4 weeks after delivery or termination of the pregnancy

Collaborators and Investigators

• Sponsor: Pregnolia AG

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2023
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 3, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Cervical Stiffness
• Other Study ID Numbers: F-405-11 v. 2.0, 2023-02-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No