Induction of labour - nulliparous subjects only Pregnancy and Childbirth Failed induction of labour
Conditions
Interventions
This was a randomised, open, comparative, non-inferiority study. Nulliparous subjects were allocated to one of two groups according to their Bishop score
values and then randomised to one of two treat
Sponsors
Alliance Pharmaceuticals Ltd (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of vaginal deliveries within 24 hours of the start of induction | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of vaginal deliveries within 12 hours of the start of induction 2. Number of caesarean section deliveries 3. Mean induction-delivery interval 4. Distribution of induction-delivery interval 5. Oxytocin augmentation requirement 6. Number of instrument-assisted vaginal deliveries 7. Incidence and mean duration of tachysystole 8. Uterine hyperstimulation with fetal heart rate changes 9. Pyrexia during labour 10. Serious neonatal morbidity or perinatal death 11. Serious maternal morbidity or death Measured at differing timepoints prior to the discharge of the patients from the hospital after the delivery of the baby. | — |
Countries
United Kingdom
Outcome results
None listed