A RANDOMISED OPEN COMPARISON OF INTRAVAGINAL APL202 (25 or 50µg) 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 NULLIPAROUS SUBJECTS.
- Conditions
- Pregnancy: induction of labour
- Registration Number
- EUCTR2004-000107-18-GB
- Lead Sponsor
- Alliance Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 415
-Nulliparous subjects, aged 18 years or over, with a singleton pregnancy suitable for induction of labour with prostaglandin cervical ripening agents.
-Pregnancy duration of at least 37 weeks.
-Subjects with an un-favourable cervix defined as a Bishop’s Score of less the 9.
-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
-Subjects who are diabetic.
-Subjects with a multi-fetal pregnancy.
-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: 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): -Number of vaginal deliveries within 24 hours of the start of induction.
- Secondary Outcome Measures
Name Time Method