Oral & Vaginal Misoprostol for Induction of Labor in Nulliparous Pregnant

Status Not yet recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05696574
Study type	Interventional
Source	Cairo University
Contact	Elsayed F. Omran, M.B.B.CH
Phone	1032205090
Email	mahmoudhamdy2251988@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	January 20, 2023
Completion date	June 20, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03442582` - Afluria Pregnancy Registry
Terminated	`NCT02161861` - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study	N/A
Not yet recruiting	`NCT05934318` - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE)	N/A
Enrolling by invitation	`NCT05415371` - Persistent Poverty Counties Pregnant Women With Medicaid	N/A
Completed	`NCT04548102` - Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman	N/A
Completed	`NCT03218956` - Protein Requirement During Lactation	N/A
Completed	`NCT02191605` - Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy	N/A
Completed	`NCT02223637` - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Recruiting	`NCT06049953` - Maternal And Infant Antipsychotic Study
Completed	`NCT02577536` - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting	`NCT06336434` - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy	Phase 1/Phase 2
Not yet recruiting	`NCT05412238` - Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months	N/A
Not yet recruiting	`NCT04786587` - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Not yet recruiting	`NCT05028387` - Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
Completed	`NCT02683005` - Study of Hepatitis C Treatment During Pregnancy	Phase 1
Completed	`NCT02783170` - Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women	Phase 4
Recruiting	`NCT02507180` - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Recruiting	`NCT02564250` - Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women	N/A
Recruiting	`NCT02619188` - Nutritional Markers in Normal and Hyperemesis Pregnancies	N/A
Completed	`NCT02408315` - Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE)	Phase 3

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Oral and Vaginal Misoprostol for Induction of Labor in Nulliparous Pregnant Women

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms