Pregnolia Bern Study
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
For Part I and Part II: - Maternal age <18 years - Vaginal bleeding - Membrane rupture - Risk situations (e.g., low-lying placenta) - Fetal demise (BASEC)
Studienstandort
Bern
(BASEC)
Sponsor
Prof. Dr. Daniel Surbek
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
PD Dr. Anda Radan
0316321010
Anda-Petronela.Radan@clutterinsel.chInselspital Frauenklinik
(BASEC)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Bern
(BASEC)
Datum der Bewilligung durch die Ethikkommission
05.08.2020
(BASEC)
ICTRP Studien-ID
nicht verfügbar
Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
nicht verfügbar
Öffentlicher Titel
nicht verfügbar
Untersuchte Krankheit(en)
nicht verfügbar
Untersuchte Intervention
nicht verfügbar
Studientyp
nicht verfügbar
Studiendesign
nicht verfügbar
Ein-/Ausschlusskriterien
nicht verfügbar
nicht verfügbar
Primäre und sekundäre Endpunkte
nicht verfügbar
nicht verfügbar
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
nicht verfügbar
Sekundäre IDs
nicht verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
nicht verfügbar
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar