Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05696574 |
Other study ID # |
MS-35-2022 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 20, 2023 |
Est. completion date |
June 20, 2023 |
Study information
Verified date |
January 2023 |
Source |
Cairo University |
Contact |
Elsayed F. Omran, M.B.B.CH |
Phone |
1032205090 |
Email |
mahmoudhamdy2251988[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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 i.e., 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.