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Cervical Stiffness in Women With Threatened Preterm Labor

Recruitingn/aAges 18 Years - anyFemalePregnolia AG
NCT07840235 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Women giving birth prematurely due to spontaneous preterm labor may exhibit signs and symptoms of preterm labor (PTL) which are mostly nonspecific. Among all women presenting in emergency with some complaints suggesting preterm labor, only about 10% will give birth within 7 days. Current clinical methods to improve diagnosis of PTL include digital examination, transvaginal cervical length assessment or the use of biomarkers; however, none of these methods have high accuracy, and it is therefore important to improve diagnosis of spontaneous PTL. There is a need for more accurate methods and tools to correctly identify imminent preterm labor in order to avoid unnecessary hospital admissions and therapy, as well as give better care for those women truly in PTL who need focused attention. Recently, cervical stiffness has been evaluated as a novel biomarker for prediction of spontaneous pr

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📋 Eligibility rules (as published)
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
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What it tests

  • Pregnolia System
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Where

1 site
Institute for the Care of Mother and Child
Prague, Czechia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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