Authors' objectives:

This assessment determines the safety, effectiveness, cost effectiveness and legal aspects of misoprostol for various uses in the first, second and third trimester for cervical ripening and induction of labour as well as the management of post partum hemorrhage.

Authors' results and conclusions: Misoprostol in the first trimester: Effectiveness: The evidence suggests that in the first trimester, misoprostol is an effective cervical priming agent prior to surgical abortion. It is as effective as gemeprost when used for this purpose. It is also effective in evacuating the uterus in missed abortions. There is limited evidence to support its use in incomplete abortions and as an abortifacient. Safety: There are studies that found an association between the use of misoprostol for attempted abortion and subsequent Mobius syndrome in live born infants. However there is a need for proper large controlled trials to confirm whether this is a strong association of correlation or not. Misoprostol in the second trimester: Effectiveness: For second trimester abortions, there is insufficient evidence for effectiveness of misoprostol as a cervical priming agent. However, there is sufficient evidence for its effectiveness for termination of pregnancy and it is also cost effective. Misoprostol for cervical ripening and induction of labour: Effectiveness: In the third trimester, there is sufficient evidence of effectiveness for oral misoprostol for induction of labour. However, the data on optimal regimens are lacking. Safety: There is evidence that demonstrates that effective oral regimens of misoprostol result in unacceptably high incidence of complications such as uterine hyperstimulation and possibly uterine rupture. There is insufficient large clinical trials to assess maternal and perinatal outcomes. Misoprostol in post partum haemorrhage: Effectiveness: There is insufficient evidence to support the use of misoprostol in prevention of postpartum hemorrhage. Safety: A number of studies have reported concerns with the usage of misoprostol in third stage of labour. Legal implications: From the legal aspect, misosprostol cannot be used in pregnancy since it has been registered only for treatment of gastric and duodenal ulcers refractory to H2-receptor antagonists.

Authors' recommendations: Based on the current evidence to date, there is sufficient safety and legal concerns not to recommend misoprostol for cervical priming, termination of pregnancy, induction of labour or postpartum hemorrhage.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.moh.gov.my/

Year Published: 2004

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Malaysia

Organisation Name: Malaysian Health Technology Assessment Unit

Contact Address: Health Technology Assessment Unit, Medical Development Division, Ministry of Health Malaysia, Level 21, PERKIM Building, Jalan Ipoh, 51200 Kuala Lumpur, Malaysia. Tel: 603 4045 7781, Fax: 603 4045 77 40

Copyright: Malaysian Health Technology Assessment Unit (MHTAU)