Pregnolia Bern Study
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
For Part I and Part II: - Maternal age <18 years - Vaginal bleeding - Membrane rupture - Risk situations (e.g., low-lying placenta) - Fetal demise (BASEC)
Lieu de l’étude
Berne
(BASEC)
Sponsor
Prof. Dr. Daniel Surbek
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
PD Dr. Anda Radan
0316321010
Anda-Petronela.Radan@clutterinsel.chInselspital Frauenklinik
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Berne
(BASEC)
Date d'approbation du comité d'éthique
05.08.2020
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
non disponible
Titre public
non disponible
Maladie en cours d'investigation
non disponible
Intervention étudiée
non disponible
Type d'essai
non disponible
Plan de l'étude
non disponible
Critères d'inclusion/exclusion
non disponible
non disponible
Critères d'évaluation principaux et secondaires
non disponible
non disponible
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
non disponible
ID secondaires
non disponible
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
non disponible
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible