- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00140114
Sublingual Versus Vaginal Misoprostol for Labor Induction at Term
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Misoprostol, a synthetic prostaglandin E1 analog, has been given both orally and vaginally for induction of labor in the third trimester.1 Vaginal misoprostol has been shown to be more efficacious than oral misoprostol in equivalent doses,2 although there is the worry of uterine tachysystole and hyperstimulation with vaginal doses of 50 µg or higher.2-4 The higher efficacy after vaginal administration may be explained by the pharmacokinetics of the drug. Zeiman et al5 showed that the systemic bioavailability of vaginally administered misoprostol is 3 times higher than that after oral administration. Plasma concentrations of its metabolite, misoprostol acid, peak one to two hours after vaginal application as compared with the peak seen 30 minutes following oral administration, and although peak levels are lower with the vaginal route, they are sustained longer and overall exposure to the drug is increased, perhaps because of the presystemic gastrointestinal or hepatic metabolism that occurs with the oral route. An additional explanation for the higher efficacy could be that there is a direct effect on the cervix that initiates the physiologic events that lead to increased uterine contractility.6 However, there seems to be a trend toward patient preference for the oral route. The sublingual route of administration has not been reported in the literature prior to 2001. Since then and partly because of issues relating to patient preference, investigators started studying the sublingual route of administration of misoprostol. In theory, the sublingual route could mimic vaginal administration pharmacokinetically, although there have been no such reported studies on this route of administration.
It is speculated that sublingual misoprostol could combine the higher efficacy of the vaginal route by avoiding gastrointestinal and hepatic metabolism, but it could have a more restrained effect on uterine contractility by avoiding direct effects on both the uterus and cervix. Therefore, in theory, the sublingual route may have lower hyperstimulation rates and would have the advantage of a less invasive administration and lack of restriction of mobility.
Although many studies have been published on the use of sublingual misoprostol for medical abortion in the first and second trimesters, 7-11, only two studies (by the same group) have compared sublingual to oral misoprostol, in different doses.12,13 The 50-µg dose was chosen because it is the dose most commonly used orally and vaginally in various studies reported in the literature.3,14 To the best of our knowledge, no study comparing sublingual to vaginal misoprostol for labor induction at term has been previously published in the literature. Therefore, this study, when completed will provide evidence on the relative effect and safety profile of different routes of administration of misoprostol for labor induction.
The aim of our study is to compare the efficacy of a 50-µg sublingual dose of misoprostol administered at 4-hour intervals with an equivalent dose regimen administered vaginally in women admitted for induction of labor for a medical or obstetric indication at term. In addition, we want to assess the safety profile and patient acceptability of the 2 modes of administration.
The study hypothesis is that the sublingual route of administration of misoprostol is as effective as the vaginal route for induction of labor at term and is more acceptable to patients as compared to vaginal misoprostol.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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-
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Beirut, Lebanon
- American University of Beirut Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: A
A: Vaginal misoprostol (cytotec)
|
50 micrograms of sublingual or vaginal misoprostol every 4 hours for a maximum of 5 doses
Other Names:
|
Other: B
Sublingual misoprostol (Cytotec)
|
50 micrograms of sublingual or vaginal misoprostol every 4 hours for a maximum of 5 doses
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The proportion of women satisfied with the route of administration of misoprostol.
Time Frame: 48 hours of enrollment
|
48 hours of enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The interval of induction to delivery
Time Frame: Within 24 hours of induction
|
Within 24 hours of induction
|
Number of doses of misoprostol given
Time Frame: Within 24 hours of induction
|
Within 24 hours of induction
|
Number of unsuccessful inductions
Time Frame: Within 24 hours of induction
|
Within 24 hours of induction
|
Number of cesarean deliveries for fetal concerns
Time Frame: Within 24 hours of randomization
|
Within 24 hours of randomization
|
The incidence of tachysystole
Time Frame: within 24 hours of randomization
|
within 24 hours of randomization
|
Collaborators and Investigators
Investigators
- Principal Investigator: Anwar H Nassar, MD, American University of Beirut Medical Center
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OGY.AN.02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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