Cervical Stiffness Assessment in High-risk Pregnancies for Preterm Birth (PilotProPre)

May 26, 2026 updated by: Gülseven Gül, Luzerner Kantonsspital

A Pilot Study of Cervical Stiffness Assessment With an Aspiration-based Device in High-risk Pregnancies for Preterm Birth

Cervical length is usually measured using ultrasound, and if it is shortened, hormone therapy (progesterone) is recommended to reduce the risk of premature birth.

The investigators want to find out what cervical stiffness is like in women with a shortened cervical length before and during hormone therapy. The investigators believe that this measurement will help to better assess the risk of premature birth in the future.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a prospective, non-interventional, post-market monocentric clinical investigation in a Swiss hospital (Lucerne Cantonal Hospital) to measure cervical stiffness on women at high risk of premature birth, defined as women with a cervical length less or equal to 25 mm presenting between 16+0 wp and 32 wp.

Cervical stiffness will be measured as Cervical Stiffness Index (CSI) using the Pregnolia System.

The primary objective is an initial characterization of the distribution of the median Cervical Stiffness Index (CSI, in mbar), corresponding to the median of three consecutive measurements at each presentation at pregnant women of gestational age between 16weeks 0 days and 32weeks 0 days with a cervical length less or equal to 25 mm before the initiation of progesterone treatment. Day 1 is when study inclusion criteria are met, informed consent is obtained and the first Cervical Stiffness Index is carried out.

Secondary objectives

  • At each presentation three consecutive CSI measurements will be carried out and as a secondary objective the first, the highest, lowest and mean measurement will be analyzed for each secondary outcome.
  • Evaluation of Cervical Stiffness Index 1, 2, 3 (CSI, in mbar) on day 10-14 and on day 24-28 after initiation of progesterone treatment, which is defined as day 1; further follow-up is not mandatory, but possible
  • Determination of a first estimate of the correlation of the initial CSI and CSI changes with birth outcome (gestational age at birth)
  • Determination of a first estimate of the correlation of CSI with cervical length (longer cervical length stiffer?)
  • Determination of first signals for potential associations of CSI with additional treatments for preterm birth (tocolysis, cerclage, pessary)
  • Determination of first signals for potential associations of CSI with neonatal outcome (birth weight, APGAR, arterial pH, admission to neonatal intensive care)
  • Safety objective: safety of the device, by assessing incidence, severity, and seriousness of device-related adverse events (discomfort, bleeding, lesion, irritation).

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Canton of Lucerne
      • Lucerne, Canton of Lucerne, Switzerland, 6000
        • Luzerner Kantonsspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

pregnant women

Description

Inclusion Criteria:

  • Informed consent signed by the participant
  • Pregnant women more or equal to 18 years of age.
  • Singleton gestation
  • Weeks of pregnancy between 16 weeks 0 days and 32 weeks and 0 days
  • Cervix less or equal to 25 mm (inferior to the 5th centile at 25 wp)
  • No regular contractions
  • Planned progesterone treatment

Exclusion Criteria:

  • Cognitively impaired adults
  • Cerclage or pessary on place
  • Ongoing progesterone (if continued or started after 13+0 wp) treatment
  • Multiple pregnancies
  • Placenta praevia totalis with hemorrhage (irrespective of severity)
  • Vasa praevia
  • Light bleeding (if the bleeding can be stopped it is no longer an exclusion criterion)
  • Heavy vaginal bleeding, hematoma or chorioamniotic membrane separation
  • Rupture of membranes (exclusion with ROM+ test if PPROM is suspected)
  • History of cervical surgery only if visible scaring at 12 o'clock
  • Cervical dilation more equal to 3 cm
  • Signs of chorioamnionitis
  • Symptomatic genital infection
  • Known carrier of HIV or Hepatitis B/C
  • Fetal malformations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cervical stiffness index (mbar) at enrollment
Time Frame: 1 day
The median of three consecutive Cervical Stiffness Index (CSI, in mbar) measurements at gestational age of 16weeks 0 days up to 32weeks 0 days before progesterone start
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cervical stiffness index (mbar) at enrollment
Time Frame: 1 day
The first, the highest, the lowest and the mean of three consecutive Cervical Stiffness Index (CSI, in mbar) measurements at gestational age of 16weeks 0 days up to 32weeks 0 days before progesterone start
1 day
cervical stiffness index (mbar) follow-up after progesterone start
Time Frame: 28 days
The median, the first, the highest, the lowest and the mean of three consecutive Cervical Stiffness Index (CSI, in mbar) measurements at two follow-up visits after 10 to 14 days
28 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events of cervical stiffness index measurement
Time Frame: days from enrollment to birth
Device-related adverse events, such as discomfort, bleeding, lesion, irritation or serious adverse events
days from enrollment to birth
correlation of cervical stiffness index (mbar) with cervical length (mm)
Time Frame: 28 days
Correlation between cervical stiffness index (mbar) and cervical length (mm) at study entrance and during follow-up
28 days
cervical stiffness index (mbar) and additional preterm treatments
Time Frame: 28 days
Correlation between cervical stiffness index (mbar) with additional need of preterm birth treatments during pregnancy (tocolysis, cerclage, pessary)
28 days
cervical stiffness index (mbar) and birth outcome
Time Frame: days from enrollment to birth
Correlation between cervical stiffness index (mbar) and the gestational age at birth (pregnancy length expressed by weeks and days at birth)
days from enrollment to birth
cervical stiffness index (mbar) and neonatal outcome
Time Frame: days from enrollment to 7 days postpartum
Correlation between cervical stiffness index (mbar) and neonatal outcome (weight at birth inferior to the 5th percentile; 5 minutes APGAR score inferior to 7; arterial blood pH inferior to 7.1; need for neonatal intensive care unit admission during the first week after birth)
days from enrollment to 7 days postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luzerner Kantonsspital

Investigators

  • Principal Investigator: Gülseven Gül, MD, Luzerner Kantonsspital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2023

Primary Completion (Actual)

September 29, 2025

Study Completion (Actual)

September 29, 2025

Study Registration Dates

First Submitted

February 15, 2026

First Submitted That Met QC Criteria

April 16, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-00032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

This requires a permission of the Swiss Ethics Committee which needs to be requested.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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