Intravaginal APL202 versus dinoprostone in the induction of labour in nulliparous subjects
- Conditions
- Induction of labour - nulliparous subjects onlyPregnancy and ChildbirthFailed induction of labour
- Registration Number
- ISRCTN27617624
- Lead Sponsor
- Alliance Pharmaceuticals Ltd (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 622
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of vaginal deliveries within 24 hours of the start of induction
- Secondary Outcome Measures
Name Time Method 1. Number of vaginal deliveries within 12 hours of the start of induction<br>2. Number of caesarean section deliveries<br>3. Mean induction-delivery interval<br>4. Distribution of induction-delivery interval<br>5. Oxytocin augmentation requirement<br>6. Number of instrument-assisted vaginal deliveries<br>7. Incidence and mean duration of tachysystole<br>8. Uterine hyperstimulation with fetal heart rate changes<br>9. Pyrexia during labour<br>10. Serious neonatal morbidity or perinatal death<br>11. Serious maternal morbidity or death<br><br>Measured at differing timepoints prior to the discharge of the patients from the hospital after the delivery of the baby.