A benefit-risk assessment of misoprostol for cervical ripening and labour induction.

Misoprostol, a prostaglandin E(1) analogue, is widely used in the US and other countries for cervical ripening and labour induction. Its use for these indications is not approved by the US Food and Drug Administration (FDA). The manufacturer of misoprostol issued a letter to American healthcare providers in August 2000, cautioning against the use of misoprostol in pregnant women and citing a lack of safety data for its use in obstetrical practice. The only FDA-approved indication in the product labelling is the treatment and prevention of intestinal ulcer disease resulting from nonsteroidal anti-inflammatory drug use. Multiple trials have proven that when applied vaginally, misoprostol is an effective agent for cervical ripening and labour induction in term pregnancy. The use of oxytocin augmentation is reduced when intravaginal misoprostol is used compared with other agents. Misoprostol use in obstetrics carries the added benefits of temperature stability at room temperature, which is unlike other prostaglandin preparations which require refrigeration or freezing, and reduced cost. However, debate continues regarding the optimal dose, dosage regimen, and route of administration. Uterine contraction abnormalities are often found in association with higher misoprostol doses (50 microg or more) given vaginally or orally. Some trials also indicate increased frequencies of meconium passage, neonatal acidaemia and caesarean delivery for fetal distress in women receiving higher doses of vaginally applied misoprostol. However, most trials fail to demonstrate a significant change in the caesarean delivery rate with the use of misoprostol, although a recent meta-analysis indicated that the use of intravaginal misoprostol is associated with a lowering of the caesarean rate when compared with pooled controls. Low-dose misoprostol (25 microg) is an effective agent for cervical ripening and labour induction when used in a judicious and cautious fashion. There are insufficient data to support the widespread use of oral misoprostol for cervical ripening and labor induction. Some trials suggest that this approach may be effective; however, the ideal dose and administration regimen have yet to be defined.