Measuring cervical softness to predict preterm birth
Assessment of Cervical SofTening and the Prediction of Preterm Birth'
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT05477381
This study is testing if measuring how soft the cervix is can help predict preterm birth in pregnant women who are at risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 390 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (other) |
| Locations | 1 site (Amsterdam, North-Holland) |
| Trial ID | NCT05477381 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the predictive value of cervical softening as a marker for preterm birth (PTB) in pregnant women. It utilizes the Pregnolia® System to measure cervical stiffness, which may provide a more accurate assessment compared to traditional cervical length measurements. The study will include women with a history of PTB and those presenting with symptoms of threatened PTB, allowing for better identification of high-risk patients. By improving prediction methods, the study seeks to enhance interventions that could postpone delivery and improve outcomes for mothers and infants.
Who should consider this trial
Good fit: Ideal candidates include pregnant women aged 18 and older with a history of spontaneous preterm birth or those experiencing threatened preterm labor between 24 and 34 weeks of gestation.
Not a fit: Patients with signs of intrauterine infection, confirmed fetal abnormalities, or those requiring immediate delivery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate predictions of preterm birth, allowing for timely interventions that improve neonatal outcomes.
How similar studies have performed: While cervical length measurement has been widely used, the approach of assessing cervical softening is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or above. * Ability to understand Dutch or English (both spoken and written). * Ultrasound-based gestational age determined by measurement of crown rump length (CRL) determined between 9 and 11 weeks of gestation. * Singleton and twin pregnancies. Cohort A-STIPP specific: - Medical history of spontaneous preterm birth before 34 weeks of gestation Cohort S-STIPP specific: * Threatened Preterm birth between 24 and 34 weeks of gestation. * Threatened preterm birth is defined as: * abdominal pain * (Braxton Hicks) contractions * vaginal blood loss. Exclusion Criteria: * Under 18 years of age. * Signs of intrauterine infection. * Obstetric indication for immediate delivery (advanced labor, cord prolapse, abruption, signs of fetal distress). * Confirmed fetal abnormality. * Confirmed preterm rupture of membranes. * Confirmed vasa / placenta praevia. * Severe vaginal bleeding and light bleeding that cannot be stopped. * Signs of imminent labor such as blood loss, regular contractions.
Where this trial is running
Amsterdam, North-Holland
- Amsterdam UMC, location AMC — Amsterdam, North-Holland, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Eva Pajkrt, Prof. Dr. — Amsterdam UMC, location AMC
- Study coordinator: Sofie Breuking, drs
- Email: s.h.breuking@amsterdamumc.nl
- Phone: + 31205669111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preterm Birth, Threatened Preterm Labor, Premature Birth, Premature Labor, Diagnosis, Cervical Incompetence, With Delivery, Cervical Incompetence in Pregnancy as Antepartum Condition