A RANDOMISED OPEN COMPARISON OF INTRAVAGINAL APL202 (25µg) FOLLOWED BY 25µg AFTER 4 AND 8 HOURS VERSUS 3mg of DINOPROSTONE AS A VAGINAL TABLET FOLLOWED BY 3mg AFTER 6 HOURS IN THE INDUCTION OF LABOUR IN MULTIPAROUS SUBJECTS.
- Conditions
- Pregnancy: induction of labour
- Registration Number
- EUCTR2004-000108-42-GB
- Lead Sponsor
- Alliance Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 415
1.Subjects, aged 18 years or over, having at least one previous term pregnancy suitable for induction of labour with prostaglandin cervical ripening agents.
2.Pregnancy duration of at least 37 weeks.
3.Subjects with an unfavourable cervix defined as a Bishop’s Score of less than 9 (see Appendix II)
4.Signed informed consent.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.Subjects who are diabetic.
2.Subjects with a multiple pregnancy.
3.Subjects in whom oxytocic drugs are generally contraindicated or where prolonged contractions of the uterus are considered inappropriate.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Main objective : To determine the safety and efficacy of 2 dosage regimens of APL-202 in the induction of labour compared to the standard agent currently used for cervical ripening.;Secondary Objective: N/A;Primary end point(s): 1.Number of vaginal deliveries within 24 hours of the start of induction.
- Secondary Outcome Measures
Name Time Method