Cervical stiffness test to help predict preterm birth in at-risk pregnant women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an observational study evaluating whether measuring cervical stiffness with the Pregnolia System can predict spontaneous preterm birth among women with symptoms of threatened preterm labor. Eligible participants are singleton pregnancies between 22 and 35+6 weeks gestation with signs of potential preterm labor, who have a recent ultrasound confirming closed cervical os and no membrane bulging. The study compares the cervical stiffness measurement to standard clinical assessments to determine its diagnostic accuracy. Findings could help reduce unnecessary hospital admissions and targeted interventions for those truly at risk.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Singleton gestation
* Aged ≥18 years
* Able to give informed consent
* Between 22 weeks, 0 days and 35 weeks, 6 days of gestation
* An ultrasound performed within 6 hours prior to CSI assessment, or after CSI assessment, showing a closed external cervical os and absence of bulging of the membranes into the cervical canal. If ultrasound was conducted by referring hospital, it shall be repeated as part of the study.
* At speculum or vaginal examination: cervical dilation less than 3 cm and no membrane seen or palpated.
* Intact membranes
* Sign and/or symptoms of threatened preterm labor: one or more of the following:

  * Abdominal pain or cramps
  * Uterine contractions, felt or unfelt
  * Bloody show ("spotting" or light bleeding)
  * Pelvic pressure
  * Low back pain (continuous or intermittent)

Exclusion Criteria:

* Signs of imminent labor such as strong, painful and intense contractions (strong suspicion of true labor).
* Cervical dilatation ≥ 3 cm
* Signs of intrauterine infection / amnionitis
* Obstetric indication for immediate delivery (advanced labor, cord prolapse, placenta abruption, signs of fetal distress)
* Confirmed fetal abnormality
* Fetal death
* Known or suspected rupture of membranes
* Confirmed vasa / placenta previa
* Severe active vaginal bleeding
* Light bleeding that cannot be stopped
* Cerclage or pessary in place
* Müllerian anomalies
* Female genital mutilation

Where it's running

• Institute for the Care of Mother and Child
  Prague, Czechia Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.