The purpose of the study is to determine the efficacy of a silicone-double-balloon-catheter for cervical ripening and labor induction in women with unfavorable cervix (Bishop Score not greater than 6) compared to medical treatment using a dinoprostone slow-release-vaginal-insert.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
253
Application of the cervical ripening double-balloon (filled with 2x 80ml) on day 1.
Application of Propess-vaginal-insert, (Dinoprostone 10mg - Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria) for labor induction on day 1-3 in therapy arm 2.
Abteilung für Gynäkologie und Geburtshilfe, Krankenhaus St. Josef Braunau
Braunau am Inn, Austria
RECRUITINGUniversitätsklinik für Frauenheilkunde und Geburtshilfe, Medizinische Universität Graz
Graz, Austria
RECRUITINGtime interval from primary treatment to delivery
the time interval between the first application of the cervical ripening balloon (therapy arm 1) to delivery and the time between first application of dinoprostone vaginal-insert (therapy arm 2) to delivery is measured
Time frame: maximum of 72 hours
progress of labor
time from balloon-application to dilatation of the cervix (cervical opening \> 3cm, or Bishop Score ≥ 9 ) in therapy arm 1 and from dinoprostone-vaginal-insert-application to dilatation of the cervix (cervical opening \> 3cm, or Bishop Score ≥ 9 ) in therapy arm 2
Time frame: maximum of 72 hours
vaginal delivery
Number of patients who achieve spontaneous vaginal delivery or vaginal-operative delivery in therapy arm 1 and 2.
Time frame: maximum of 72 hours
failed induction of labor
Number of patients who received caesarean section after frustrating induction of labor. Frustrating induction is defined as application of the cervical-ripening-balloon + 2 times application of dinoprostone-vaginal-insert in therapy arm 1 and 3 times application of dinoprostone-vaginal-insert in therapy arm 2.
Time frame: maximum of 72 hours
patient's satisfaction
Patient's satisfaction with treatment is evaluated with a questionnaire within 48 h after delivery
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5-7 days
maternal parameters
signs of infection (temperature, CRP, WBC), childbirth--related injuries,need for epidural in therapy arm 1 and 2.
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Abteilung für Gynäkologie und Geburtshilfe, LKH Hartberg
Hartberg, Austria
RECRUITINGUniversitätsfrauenklinik Innsbruck, Medizinische Universität Innsbruck
Innsbruck, Austria
RECRUITINGAbteilung für Gynäkologie und Geburtshilfe, Perinatalzentrum, Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria
NOT_YET_RECRUITINGUniversitätsklinik für Frauenheilkunde und Geburtshilfe, Landeskrankenhaus Salzburg - Universitätsklinikum der Paracelsus Medizinischen Privatuniversität
Salzburg, Austria
RECRUITINGUniversitätsfrauenklinik Wien, Abteilung für Geburtshilfe und fetomaternale Medizin, Medizinische Universität Wien
Vienna, Austria
RECRUITINGTime frame: primary treatment - 48h postpartal, leading to a maximum time frame of 5 days
fetal parameters
umbilical cord blood values, apgar score, fetal birth weight,number of admissions to ICU and days at ICU in therapy arm 1 and 2.
Time frame: primary treatment - fetal hospital discharge, with an expected maximum of 3 months