Pregnolia Bern Study
Descrizione riassuntiva dello studio
Part I: Pregnant women presenting with signs of impending preterm labor (back pain, contractions, cramps, pressure downwards) and between the 24th and 34th weeks of pregnancy are examined. Established examinations are supplemented by measuring the stiffness of the cervix and a special swab. The results of the additional examinations do not influence further treatment. Data is then collected to investigate the predictive power of the new test (timing of delivery, mode of delivery, weight of the child, etc.). As a control group, pregnant women without signs of preterm labor are examined as part of routine check-ups between the 24th and 34th weeks of pregnancy. Part II: Pregnant women requiring labor induction are examined with the device for measuring cervical stiffness before the induction begins. The result does not influence the type of induction. Data is then collected to investigate the predictive power of the new test (timing of delivery, mode of delivery, weight of the child, etc.).
(BASEC)
Intervento studiato
Measurement of cervical stiffness during normal pregnancies, in cases of impending preterm labor and before labor induction in patients with a previous cesarean section.
(BASEC)
Malattie studiate
Part I: This study investigates whether a new device for measuring cervical stiffness during pregnancy can better predict the risk of preterm labor than previous methods. Part II: This study investigates whether a new device for measuring cervical stiffness during pregnancy can predict the success rate and the time in which labor induction in patients leads to a vaginal delivery.
(BASEC)
Part I Study Group - Signs of impending preterm labor - Between the 24th and 34th weeks of pregnancy - Less than 3 cm dilated cervix - No signs of membrane rupture - Singleton or twin pregnancy Part I Control Group - No signs of impending preterm labor - Between the 24th and 34th weeks of pregnancy - No risk factors for preterm labor Part II - Planned labor induction - Between the 38th and 42nd weeks of pregnancy - No signs of membrane rupture - Bishop score (cervical assessment) <7 - Singleton or twin pregnancy (BASEC)
Criteri di esclusione
For Part I and Part II: - Maternal age <18 years - Vaginal bleeding - Membrane rupture - Risk situations (e.g., low-lying placenta) - Fetal demise (BASEC)
Luogo dello studio
Berna
(BASEC)
Sponsor
Prof. Dr. Daniel Surbek
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
PD Dr. Anda Radan
0316321010
Anda-Petronela.Radan@clutterinsel.chInselspital Frauenklinik
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
05.08.2020
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
Evaluation of new methods to predict preterm birth in women with signs of preterm labor and to predict success of induction of labor in women at term with an indication for induction (BASEC)
Titolo accademico
non disponibile
Titolo pubblico
non disponibile
Malattie studiate
non disponibile
Intervento studiato
non disponibile
Tipo di studio
non disponibile
Disegno dello studio
non disponibile
Criteri di inclusione/esclusione
non disponibile
non disponibile
Endpoint primari e secondari
non disponibile
non disponibile
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
non disponibile
ID secondari
non disponibile
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
non disponibile
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile