ISRCTN27617624CompletedNot Applicable
A randomised open comparision of intravaginal APL202 (25 or 50 µg) followed by 25 µg after 4 and 8 hours versus 3 mg of dinoprostone as a vaginal tablet followed by 3 mg after 6 hours in the induction of labour in nulliparous subjects
Alliance Pharmaceuticals Ltd (UK)0 sites622 target enrollmentStarted: January 15, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 622
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •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 Score of less than 9
- •4. Signed informed consent
Exclusion Criteria
- •1. Subjects requiring insulin to control their diabetes. Subjects with controlled Type II or gestational diabetes that did not require insulin could be included.
- •2. Subjects with a multiple pregnancy
- •3. Subjects in whom oxytocic drugs were generally contraindicated or where prolonged contractions of the uterus were considered inappropriate, i.e.:
- •3.1. History of caesarean section or major uterine surgery
- •3.2. Cephalopelvic disproportion
- •3.3. Foetal malpresentation
- •3.4. Clinical suspicion or definite evidence of pre-existing foetal distress
- •4. Subjects with an intercurrent vaginal, systemic or ascending infection
- •5. Subjects with clinical suspicion or definite evidence of placenta praevia or unexplained vaginal bleeding during their pregnancy. Occasional spotting, considered by the Investigator to be of no clinical significance concerning the use of cervical ripening agents and having a reasonable explanation (e.g. cervical ectropion, cervical polyps), was not a reason for exclusion.
- •6. Subjects with active cardiac, pulmonary, renal or hepatic disease
- •7. Subjects with abruptio placenta
- •8. Subjects with ruptured membranes
- •9. Subjects with a known allergy to prostaglandins or other constituents of the tablets
- •10. Subjects with any contraindication to vaginal delivery (e.g., active genital herpes)
Investigators
Similar Trials
Completed
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Intravaginal APL202 verus dinoprostone in the induction of labour in multiparous subjectsInduction of labour - multiparous subjectsPregnancy and ChildbirthFailed induction of labourISRCTN36773557Alliance Pharmaceuticals Ltd (UK)622
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Phase 1
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.Pregnancy: induction of labourEUCTR2004-000108-42-GBAlliance Pharmaceuticals415
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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.Pregnancy: induction of labourEUCTR2004-000107-18-GBAlliance Pharmaceuticals415
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