Success rate of initiation of birth process at term by inserting a balloon into the cervix compared by inserting a vaginal delivery system (dinoprostone).

• Conditions: Gestational age between the 37th and 42th gestation week; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2012-004880-36-AT
• Lead Sponsor: Medizinische Universität Graz, Klinische Abteilung für Geburtshilfe, Univ. Klinik für Frauenheilkunde und Geburtshilfe

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-29
• Last Update Posted: 24 June 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Maternal age > 18 years Alter
Signed Informed Consent
Singleton Pregnancy
Cephalic presentation
no preterm rupture of membranes
gestational age: 37+0 – 42+0 weeks
unfavourable cervix (Bishop-Score = 6)
absence of contra-indications for pharmaceutical induction of labor
no clinical signs of infection or inflammation (temperature < 37,5, WBC < 20.000, C-reactive protein < 20)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 253
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
;
Maternal age > 18 years Alter
Signed Informed Consent
Singleton Pregnancy
Cephalic presentation
no preterm rupture of membranes
gestational age: 37+0 – 42+0 weeks
unfavourable cervix (Bishop-Score = 6)
absence of contra-indications for pharmaceutical induction of labor
no clinical signs of infection or inflammation (temperature < 37,5, WBC < 20.000, C-reactive protein < 20)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 253
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Fetal malformation
Presence of contra-indications for pharmaceutical induction of labor
Placentation disorders
History of uterine surgery with opening of the uterine cavum incl. ceasaren section.
preterm rupture of membranes
multiple gestations
gestational age < 37+0 weeks
History of surgery for cervical tear

;
Fetal malformation
Presence of contra-indications for pharmaceutical induction of labor
Placentation disorders
History of uterine surgery with opening of the uterine cavum incl. ceasaren section.
preterm rupture of membranes
multiple gestations
gestational age < 37+0 weeks
History of surgery for cervical tear

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified