Induction of labour in nulliparous and multiparous women: a UK, multicentre, open-label study of intravaginal misoprostol in comparison with dinoprostone.
OBJECTIVE
To compare the efficacy and safety of a 25-microgram vaginal tablet of misoprostol (APL202) with dinoprostone (3-mg vaginal tablet) in cervical ripening and labour induction.


METHODS
A randomised, open-label, noninferiority, comparative study in two maternal populations.


METHODS
Eighteen NHS study centres across the UK.


METHODS
Nulliparous or multiparous women with a singleton pregnancy eligible for induction of labour.


METHODS
Women were randomised to receive either misoprostol, initially 25 micrograms (50 micrograms in nulliparous women with Bishop score < or =4) followed by 25 micrograms after 4 and 8 hours, or dinoprostone, initially 3 mg followed by 3 mg after 6 hours. Clinical noninferiority of misoprostol was defined as an absolute difference between treatments of no more than 10% for the primary outcome.


METHODS
The number of vaginal deliveries achieved within 24 hours of labour induction. Maternal and fetal safety outcomes.


RESULTS
A total of 626 women were randomised to misoprostol (n = 318) or dinoprostone (n = 308) treatment. The rate of vaginal deliveries achieved within 24 hours of induction did not significantly differ between the misoprostol and dinoprostone (43 versus 47%; 3.74% difference, 95% CI -3.58 to 11.05, respectively) treatment groups. The treatments were generally comparable for other secondary efficacy measures. Maternal and fetal adverse events were similarly distributed across the misoprostol and dinoprostone groups.


CONCLUSIONS
Low-dose misoprostol is efficacious in cervical ripening and labour induction and demonstrates a similar fetal and maternal safety profile to dinoprostone.
Calder
A A
AA
Simpson Centre for Reproductive Health, Royal Infirmary of Edinburgh, Edinburgh, UK.
Loughney
A D
AD
Weir
C J
CJ
Barber
J W
JW
D000282:Administration, Intravaginal; D000293:Adolescent; D000328:Adult; D020070:Cervical Ripening / Q000187:drug effects*; D015232:Dinoprostone / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007751:Labor, Induced / Q000379:methods*; D016595:Misoprostol / Q000008:administration & dosage* / Q000009:adverse effects; D010120:Oxytocics / Q000008:administration & dosage* / Q000009:adverse effects; D010298:Parity; D011247:Pregnancy; D013607:Tablets; D016896:Treatment Outcome
D010120:Oxytocics; D013607:Tablets; D016595:Misoprostol; D015232:Dinoprostone