Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00140114
Status:
COMPLETED
Last Update Posted:
2012-07-13
First Post:
2005-08-31
Brief Title:
Sublingual Versus Vaginal Misoprostol for Labor Induction at Term
Sponsor:
American University of Beirut Medical Center
Organization:
American University of Beirut Medical Center
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Misoprostol a synthetic prostaglandin E1 analog has been given both orally and vaginally for induction of labor in the third trimester1 Vaginal misoprostol has been shown to be more efficacious than oral misoprostol in equivalent doses2 although there is the worry of uterine tachysystole and hyperstimulation with vaginal doses of 50 µg or higher2-4 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 contractility6 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 doses1213 The 50-µg dose was chosen because it is the dose most commonly used orally and vaginally in various studies reported in the literature314 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
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 doses1213 The 50-µg dose was chosen because it is the dose most commonly used orally and vaginally in various studies reported in the literature314 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None