Sublingual Versus Vaginal Misoprostol for Labor Induction at Term

NCT00140114 | Completed Phase 3 DMC

• 1 other identifier: OGY.AN.02
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Induction of Labor

Keywords

Vaginal, sublingual, misoprostol, cervical ripening

Outcome Measures

Primary Outcomes (1)

• The proportion of women satisfied with the route of administration of misoprostol.

  48 hours of enrollment

Secondary Outcomes (5)

• The interval of induction to delivery

  Within 24 hours of induction

• Number of doses of misoprostol given

  Within 24 hours of induction

• Number of unsuccessful inductions

  Within 24 hours of induction

• Number of cesarean deliveries for fetal concerns

  Within 24 hours of randomization

• The incidence of tachysystole

  within 24 hours of randomization

Study Arms (2)

A

OTHER

A: Vaginal misoprostol (cytotec)

Drug: Misoprostol (Cytotec®)

B

OTHER

Sublingual misoprostol (Cytotec)

Drug: Misoprostol (Cytotec®)

Interventions

Misoprostol (Cytotec®) DRUG

50 micrograms of sublingual or vaginal misoprostol every 4 hours for a maximum of 5 doses

Also known as: Cytotec

A; B

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Anwar H Nassar, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 1, 2005
• Study Start: January 1, 2004
• Study Completion: September 1, 2006
• Last Updated: July 13, 2012

Record last verified: 2008-08

Locations

LE (1)