Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05696574
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-01-25
First Post:
2023-01-05
Brief Title:
Oral and Vaginal Misoprostol for Induction of Labor in Nulliparous Pregnant Women
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Comparative Study Between Oral and Vaginal Misoprostol for Induction of Labor in Nulliparous Pregnant Women at or Beyond Completed 41 Weeks
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-01
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:
The aim of this study is to compare the efficacy and the safety of vaginal misoprostol with oral misoprostol for induction of labor in nulliparous pregnant women at or beyond completed 41 weeks
Detailed Description:
Induction of labor is carried out for maternal and fetal indications and one of the most common indications is prolonged pregnancy
Recent studies have suggested that by continuing pregnancy beyond 41 weeks there is statistically significantly higher perinatal morbidity and mortality as well as an increased risk to the mother Thus there is a growing body of evidence suggesting the elective induction of labor at 41 weeks of gestation instead of expectant management
Misoprostol a prostaglandin E1 analog is indicated for protection against gastric ulcers but when administered prenatally it causes uterine contractions Research exploiting this adverse effect has shown misoprostol to be superior to conventional methods for induction resulting in shorter induction-to-delivery intervals without any increase in adverse outcomes It has the advantage of being cheap stable at room temperature and easy to be administered by various routes ie vaginal oral sublingual or rectal
The differential outcomes of oral versus vaginal misoprostol may be secondary to different pharmacokinetics for oral compared with vaginal misoprostol Oral misoprostol undergoes rapid absorption from the gastrointestinal tract and rapid and extensive de-esterification during first-pass metabolism to an active metabolite misoprostol peaking at 15 minutes with a half-life of 20-40 minutes Misoprostol then undergoes early rapid elimination over 120 minutes followed by slow elimination thereafter The medication rapidly makes its way to the myometrium ln contrast after vaginal misoprostol administration plasma concentration gradually increase reaching a maximum level after 70-80 minutes before slowly being eliminated with plasma levels still detectable 6 hours after administration
Recent studies have suggested that by continuing pregnancy beyond 41 weeks there is statistically significantly higher perinatal morbidity and mortality as well as an increased risk to the mother Thus there is a growing body of evidence suggesting the elective induction of labor at 41 weeks of gestation instead of expectant management
Misoprostol a prostaglandin E1 analog is indicated for protection against gastric ulcers but when administered prenatally it causes uterine contractions Research exploiting this adverse effect has shown misoprostol to be superior to conventional methods for induction resulting in shorter induction-to-delivery intervals without any increase in adverse outcomes It has the advantage of being cheap stable at room temperature and easy to be administered by various routes ie vaginal oral sublingual or rectal
The differential outcomes of oral versus vaginal misoprostol may be secondary to different pharmacokinetics for oral compared with vaginal misoprostol Oral misoprostol undergoes rapid absorption from the gastrointestinal tract and rapid and extensive de-esterification during first-pass metabolism to an active metabolite misoprostol peaking at 15 minutes with a half-life of 20-40 minutes Misoprostol then undergoes early rapid elimination over 120 minutes followed by slow elimination thereafter The medication rapidly makes its way to the myometrium ln contrast after vaginal misoprostol administration plasma concentration gradually increase reaching a maximum level after 70-80 minutes before slowly being eliminated with plasma levels still detectable 6 hours after administration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None