ISRCTN36773557CompletedNot Applicable
A randomised open comparison of intravaginal APL202 (25 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 multiparous 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, who had 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 do not require insulin may be included.
- •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, 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
- •3.5. History of difficult labour and/or traumatic delivery
- •3.6. Grand multiparae with over 5 previous term pregnancy
- •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), is not a reason for exclusion.
- •6. Subjects with active cardiac, pulmonary, renal or hepatic disease
- •7. Subjects with abruptio placenta. Abruptio placenta in a previous pregnancy is not a reason for exclusion.
- •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
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