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

Phase 4

• Conditions: Cervical Ripening; Induction of Labor
• Interventions: Device: Cervical Ripening Balloon, Cook Medical Inc.; Drug: Dinoprostone

• Registration Number: NCT01720394
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-25
• Study First Submitted QC: 2012-10-31
• Study First Posted: 2012-11-02
• Study Start: 2013-11
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-07
• Last Update Posted: 2018-09-11
• Primary Completion: 2019-07
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 253

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cervical ripening balloon	Cervical Ripening Balloon, Cook Medical Inc.	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.
Propess	Dinoprostone	Primary treatment using dinoprostone-vaginal-inserts on day 1-3 if no progression of labor (Bishop Score ≥ 9 and/or cervical dilatation ≥ 3 cm)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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

Trial Locations

Locations (7)

Universitätsfrauenklinik Innsbruck, Medizinische Universität Innsbruck; 🇦🇹 Innsbruck, Austria

Universitätsklinik für Frauenheilkunde und Geburtshilfe, Medizinische Universität Graz; 🇦🇹 Graz, Austria

Universitätsfrauenklinik Wien, Abteilung für Geburtshilfe und fetomaternale Medizin, Medizinische Universität Wien; 🇦🇹 Vienna, Austria

Abteilung für Gynäkologie und Geburtshilfe, LKH Hartberg; 🇦🇹 Hartberg, Austria

Abteilung für Gynäkologie und Geburtshilfe, Perinatalzentrum, Klinikum Klagenfurt am Wörthersee; 🇦🇹 Klagenfurt, Austria

Abteilung für Gynäkologie und Geburtshilfe, Krankenhaus St. Josef Braunau; 🇦🇹 Braunau, Austria

Universitätsklinik für Frauenheilkunde und Geburtshilfe, Landeskrankenhaus Salzburg - Universitätsklinikum der Paracelsus Medizinischen Privatuniversität; 🇦🇹 Salzburg, Austria