NCT07541313

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 27, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

February 15, 2026

Last Update Submit

April 20, 2026

Conditions

Cervical InsufficiencyCervical Stiffness

Keywords

cervical insufficiencycervical stiffnessshort cervixcervical lenghtpreterm birth risk

Outcome Measures

Primary Outcomes (1)

  • cervical stiffness index (mbar) at enrollment

    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 Outcomes (1)

  • cervical stiffness index (CSI) (mbar) follow-up after progesterone start

    28 days

Other Outcomes (4)

  • Correlation of cervical stiffness index (mbar) with cervical length (mm)

    28 days

  • Cervical stiffness index (mbar) and additional preterm treatments

    28 days

  • Cervical stiffness index (mbar) and neonatal outcome

    days from enrollment to 7 days postpartum

  • +1 more other outcomes

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pregnant women

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Heavy vaginal bleeding, hematoma or chorioamniotic membrane separation
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Luzerner Kantonsspital

Lucerne, Canton of Lucerne, 6000, Switzerland

Location

Related Publications (3)

  • Badir S, Mazza E, Zimmermann R, Bajka M. Cervical softening occurs early in pregnancy: characterization of cervical stiffness in 100 healthy women using the aspiration technique. Prenat Diagn. 2013 Aug;33(8):737-41. doi: 10.1002/pd.4116. Epub 2013 Apr 29.

    PMID: 23553612BACKGROUND

  • Badir S, Bajka M, Mazza E. A novel procedure for the mechanical characterization of the uterine cervix during pregnancy. J Mech Behav Biomed Mater. 2013 Nov;27:143-53. doi: 10.1016/j.jmbbm.2012.11.020. Epub 2012 Dec 11.

    PMID: 23274486BACKGROUND

  • Badir S, Bernardi L, Feijo Delgado F, Quack Loetscher K, Hebisch G, Hoesli I. Aspiration technique-based device is more reliable in cervical stiffness assessment than digital palpation. BMC Pregnancy Childbirth. 2020 Jul 6;20(1):391. doi: 10.1186/s12884-020-03080-x.

    PMID: 32631265BACKGROUND

Related Links

MeSH Terms

Conditions

Uterine Cervical Incompetence

Condition Hierarchy (Ancestors)

Uterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesAbortion, HabitualAbortion, SpontaneousPregnancy ComplicationsGenital Diseases

Study Officials

  • Gülseven Gül, MD

    Luzerner Kantonsspital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 15, 2026

First Posted

April 21, 2026

Study Start

July 27, 2023

Primary Completion

September 29, 2025

Study Completion

September 29, 2025

Last Updated

April 23, 2026

Record last verified: 2026-04

Locations

CH(1)