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

Sponsor

Pregnolia AG (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05858775

Collaborator

(none)

Enrollment

Locations

19.6

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cervix; Pregnancy	Device: Pregnolia System

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

May 15, 2023

Anticipated Primary Completion Date :

Oct 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Cervical Stiffness Index at 16+0 - 22+6 [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	gynosense AG	Uster		Switzerland
2	University Hospital Zurich	Zürich		Switzerland

Sponsors and Collaborators

Pregnolia AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pregnolia AG

ClinicalTrials.gov Identifier:

NCT05858775

Other Study ID Numbers:

F-405-11 v. 2.0, 2023-02-1

First Posted:

May 15, 2023

Last Update Posted:

May 15, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pregnolia AG

Cervical Stiffness

Study Results

No Results Posted as of May 15, 2023