Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert - a Multicenter Randomized Controlled Trial

Conditions
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Cervical Ripening, Induction of Labor

Intervention / Treatment
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* Device: Cervical Ripening Balloon, Cook Medical Inc.
* Drug: Dinoprostone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cervical ripening balloon<br>primary treatment with the cervical ripening balloon on day 1. removal of the balloon latest after 12 h. If no progression of labor (Bishop Score ≥ 9 and/or cervical opening ≥ 3 cm) continuing of standard treatment using dinoprostone vaginal-inserts on day 2 and if necessary on day 3. | Device: Cervical Ripening Balloon, Cook Medical Inc.<br>* Application of the cervical ripening double-balloon (filled with 2x 80ml) on day 1.<br>* Other names: Propess-vaginal-insert (Dinoprostone 10mg), Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria;|
| Active Comparator: Propess<br>Primary treatment using dinoprostone-vaginal-inserts on day 1-3 if no progression of labor (Bishop Score ≥ 9 and/or cervical dilatation ≥ 3 cm) | Drug: Dinoprostone<br>* 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.<br>* Other names: Propess, (Dinoprostone 10mg), Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time 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 | maximum of 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | maximum of 72 hours | 
| vaginal delivery | Number of patients who achieve spontaneous vaginal delivery or vaginal-operative delivery in therapy arm 1 and 2. | 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. | maximum of 72 hours | 
| patient's satisfaction | Patient's satisfaction with treatment is evaluated with a questionnaire within 48 h after delivery | 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. | 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. | primary treatment - fetal hospital discharge, with an expected maximum of 3 months |