Sublingual Versus Vaginal Misoprostol for Labor Induction at Term

• Status: Completed
• Trial end date: 2006-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

Misoprostol (Cytotec®) is a synthetic prostaglandin E1 analog that has been marketed in the United States since 1988 as a gastric cytoprotective agent. In contradistinction to prostaglandin E2 preparations (dinoprostone, Prepidil, Cervidil), misoprostol is inexpensive and available in scored tablets that can be broken and inserted vaginally. Despite a focused campaign by the manufacturer to curtail its use in obstetric practice, misoprostol has, over the past several years, gained widespread acceptance as both a labor induction and a cervical ripening agent. Such off-label indication has been endorsed by the American College of Obstetricians and Gynecologists and other medical bodies. Recently, FDA approved a new label for the use of cytotec during pregnancy which removed pregnancy as a contraindication for its use. Vaginal administration seems to be more efficacious than when given orally, although there is the worry of uterine tachysystole and hyperstimulation with vaginal doses > 50-µg. The use of sublingual misoprostol for cervical ripening at term was recently investigated in two studies that compared it to the oral route, on the assumption that the sublingual route would have the higher efficacy of the vaginal route by avoiding the first pass effects of the gastrointestinal and hepatic systems, while having lower hyperstimulation rates by avoiding the direct effects on the cervix. In addition, the sublingual route would combine an easier administration with the added advantage of no restriction of mobility after administration. There has been no previous report in the literature comparing the use of misoprostol given sublingually to that given vaginally for the induction of labor at term. Our aim is to compare efficacy, safety and patient satisfaction with misoprostol given vaginally (the current standard) to that given sublingually.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: American University of Beirut Medical Center
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

• Live singleton pregnancy at a gestational age of 36 wks or more with a medical or obstetric indication for induction

• Both nulliparous and multiparous women

• A cephalic presentation

• An unfavorable cervix (Bishop's score less than 8)

• A reassuring fetal heart tracing.

Exclusion Criteria:

• Rupture of membranes

• Multiple gestation

• Malpresentation (presentation other than cephalic)

• Previous cesarean delivery

• Known contraindications to the use of prostaglandins (e.g. asthma)

• Grandmultiparity (more than 5)

• Significant fetal or maternal concerns that made induction necessary under continuous monitoring (e.g. severe IUGR, severe preeclampsia)