Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor
Summary
The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.
Description
Induction of labor is required in approximately 20% of pregnant women. Although contractions can be brought on by oxytocin ("pitocin"), some women need help in softening the cervix, or mouth of the womb (uterus), before oxytocin can be started. Prostaglandins have been shown to ripen, or soften, the cervix; at present, the only prostaglandin approved for marketing by FDA for this purpose is dinoprostone. Dinoprostone can be delivered in several ways; one method is to use a polymer vaginal insert that slowly releases the dinoprostone directly to the cervical tissues. This product is called Cervidil (R) and has been marketed for more than 10 years in the United States. Misoprostol is another form of prostaglandin that is approved for protecting the stomach and intestinal lining for patients taking NSAIDs. Misoprostol has also been used by many obstetricians for cervical ripening and inducing contractions, but, it is not approved by FDA for this purpose.
The same company that makes the Cervidil polymer insert has made an insert that will slowly release misoprostol. This study will determine whether this investigational insert containing misoprostol will decrease time to vaginal delivery compared to Cervidil. Two different doses of misoprostol will be tested (50 micrograms and 100 micrograms); each vaginal insert will gradually release a small, controlled amount of misoprostol over up to 24 hours.
Comparator: The Cervidil (R) vaginal insert containing dinoprostone will be the comparator in this study.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Conditions
Cervical Ripening
Intervention
Misoprostol vaginal insert 100 mcg, Misoprostol vaginal insert 50 mcg, Dinoprostone vaginal insert (Cervidil)
Location
University of Alabama at Birmingham Medical Center
Birmingham
Alabama
United States
35249
Status
Completed
Source
Cytokine PharmaSciences
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00308711
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Vaginal Smears
Collection of pooled secretions of the posterior vaginal fornix for cytologic examination.
Episiotomy
An incision of the posterior vaginal wall and a portion of the pudenda which enlarges the vaginal introitus to facilitate delivery and prevent lacerations.
Vaginal Neoplasms
Tumors or cancer of the VAGINA.
Vaginal Diseases
Pathological processes of the VAGINA.
Hysterectomy, Vaginal
Removal of the uterus through the vagina.
Clinical Trials
Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour
The primary objective of the study was assessment of the efficacy of four dose reservoirs (25 mcg, 50 mcg, 100 mcg, 200 mcg) of intravaginal controlled release misoprostol administered for...
Pharmacokinetics and Safety of the 100 Mcg Misoprostol Vaginal Insert (MVI 100)
This study will provide pharmacokinetic data for the MVI 100 (100 mcg) misoprostol vaginal insert when administered to nulliparous women at term gestation requiring cervical ripening and i...
Efficacy and Safety Study of the Misoprostol Vaginal Priming Insert (MVPI) Prior to Hysteroscopy
A Phase II, multicenter, double-blind, randomized, placebo-controlled, dose-ranging, study to assess the efficacy and safety of the 100, 200, 400, 800, 1200 and 1600 mcg Misoprostol Vagina...
24-Hour Vaginal Dinoprostone Pessary Versus Gel for Labour Induction
The aim of induction of labour is to initiate labour when maternal and fetal conditions necessitate delivery before the onset of spontaneous contractions. Prostaglandins are widely used fo...
Comparison of Two Regimens of Misoprostol for Second Trimester Medical Termination of Pregnancy
The hypothesis of the study is that the induction abortion interval time will be significantly shorter in the group receiving vaginal misoprostol every six hours in comparison to the group...
PubMed Articles
OBJECTIVE: We compared the safety and effectiveness of oxytocin, dinoprostone and misoprostol for cervical priming. STUDY DESIGN: A total of 218 patients were enrolled to receive between one and three...
Abstract Objective: To compare the efficacy and safety of two methods for induction of labor after previous cesarean section. Methods: To compare 247 women with a previous cesarean section who were in...
Effectiveness of misoprostol for office hysteroscopy without anesthesia in infertile patients.
OBJECTIVE: To evaluate and compare the effectiveness of oral and vaginal misoprostol versus placebo to facilitate office hysteroscopy without anesthesia during infertile diagnostic evaluation. DESIGN:...
Aim: To compare immediate induction with vaginal misoprostol tablets and immediate induction with vaginal dinoprostone (naturally occurring prostaglandin E(2) [PGE(2) ]) gel in women with premature...
PURPOSE: Absorption and effectiveness of vaginally administered misoprostol tablets may vary according to the medium in which it is placed. This study was directed to compare the outcomes of vaginal a...
