Pregnolia Bern Study
Summary description of the study
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 under investigation
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)
Disease under 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)
Exclusion criteria
For Part I and Part II: - Maternal age <18 years - Vaginal bleeding - Membrane rupture - Risk situations (e.g., low-lying placenta) - Fetal demise (BASEC)
Trial sites
Bern
(BASEC)
Sponsor
Prof. Dr. Daniel Surbek
(BASEC)
Contact
Contact Person Switzerland
PD Dr. Anda Radan
0316321010
Anda-Petronela.Radan@clutterinsel.chInselspital Frauenklinik
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
05.08.2020
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available