Cervical Ripening, Induction of Labor
Conditions
Brief summary
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.
Interventions
DEVICECervical Ripening Balloon, Cook Medical Inc.
Application of the cervical ripening double-balloon (filled with 2x 80ml) on day 1.
DRUGDinoprostone
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.
Sponsors
Medical University of Vienna
Medical University Innsbruck
Klinikum Klagenfurt am Wörthersee
University of Salzburg
Hospital Hartberg, Austria
Hospital Braunau, Austria
Medical University of Graz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* medical indication for induction of labor * 18 years of age * signed informed consent * cephalic presentation * no PROM * 37+0 - 42+0 weeks of gestation * Bishop-Score ≤ 6 * no contra-indication for medical induction of labor * no clinical signs of infection
Exclusion criteria
* fetal anomalies * contra-indications for medical induction of labor * placental pathologies * St.p. surgery with opening the uterine cavity (incl. caesarean section) * PROM * multiple gestations * \< 37-0 weeks of gestation * St.p. cervical tear
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time interval from primary treatment to delivery | maximum of 72 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| vaginal delivery | maximum of 72 hours | Number of patients who achieve spontaneous vaginal delivery or vaginal-operative delivery in therapy arm 1 and 2. |
| failed induction of labor | maximum of 72 hours | 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. |
| progress of labor | maximum of 72 hours | 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 |
| maternal parameters | primary treatment - 48h postpartal, leading to a maximum time frame of 5 days | signs of infection (temperature, CRP, WBC), childbirth--related injuries,need for epidural in therapy arm 1 and 2. |
| fetal parameters | primary treatment - fetal hospital discharge, with an expected maximum of 3 months | umbilical cord blood values, apgar score, fetal birth weight,number of admissions to ICU and days at ICU in therapy arm 1 and 2. |
| patient's satisfaction | participants will be followed for the duration of hospital stay, an expected average of 5-7 days | Patient's satisfaction with treatment is evaluated with a questionnaire within 48 h after delivery |
Countries
Austria
Contacts
Primary ContactPhilipp Reif, MD
Backup ContactPhilipp Klaritsch, MD
Outcome results
None listed