- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00374621
Trial of Cervical Ripening and Labor Induction Using Misoprostol With or Without Intravaginal Isosorbide Mononitrate
April 24, 2017 updated by: Yasser Yehia El-Sayed, Stanford University
Randomized Clinical Trial of Cervical Ripening and Labor Induction Using Stepwise Oral Misoprostol With or Without Intravaginal Isosorbide Mononitrate
The purpose of this study is to determine the efficacy and safety of the addition of intravaginal isosorbide mononitrate to an established protocol of oral misoprostol for cervical ripening and labor induction.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
156
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria::
- Pregnant women
- 18 years of age or greater
- Singleton pregnancy between 32-42 weeks gestation requiring labor induction
- Membranes must be intact
Exclusion Criteria:
- Ruptured membranes
- Gestational age less than 32 weeks
- Non-reassuring fetal heart rate tracing
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Misoprostol
|
Misoprostol 50 micrograms orally then 100 micrograms every 4 hours for up to four doses until modified Bishop score of 8 or higher was observed vs. the same misoprostol dosing plus isosorbide mononitrate 40 mg vaginally every 6 hours up to two doses total until a modified Bishop sore of at least 8 was observed
|
Active Comparator: Misoprostol with Isosorbide Mononitrate
|
Misoprostol 50 micrograms orally then 100 micrograms every 4 hours for up to four doses until modified Bishop score of 8 or higher was observed vs. the same misoprostol dosing plus isosorbide mononitrate 40 mg vaginally every 6 hours up to two doses total until a modified Bishop sore of at least 8 was observed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to vaginal delivery
Time Frame: First dose of study medication to delivery
|
First dose of study medication to delivery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yasser Yehia El-Sayed, Stanford University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
January 1, 2010
Study Registration Dates
First Submitted
September 7, 2006
First Submitted That Met QC Criteria
September 7, 2006
First Posted (Estimate)
September 11, 2006
Study Record Updates
Last Update Posted (Actual)
April 25, 2017
Last Update Submitted That Met QC Criteria
April 24, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Gastrointestinal Agents
- Natriuretic Agents
- Diuretics, Osmotic
- Diuretics
- Reproductive Control Agents
- Anti-Ulcer Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Oxytocics
- Nitric Oxide Donors
- Misoprostol
- Isosorbide
- Isosorbide Dinitrate
- Isosorbide-5-mononitrate
Other Study ID Numbers
- 97274
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Ripening
-
Western Galilee Hospital-NahariyaRecruiting
-
Universidad de la RepublicaCompleted
-
Zekai Tahir Burak Women's Health Research and Education...UnknownCervical RipeningTurkey
-
Henry Ford Health SystemCompletedCervical Ripening
-
Ferring PharmaceuticalsCompleted
-
University Hospital, Strasbourg, FranceCompletedCervical RipeningFrance
-
Ferring PharmaceuticalsCompleted
-
Planned Parenthood League of MassachusettsSociety of Family PlanningCompleted
-
Cairo UniversityUnknownCervical RipeningEgypt
-
Wenzhou Medical UniversityUnknown
Clinical Trials on Misoprostol with or without isosorbide mononitrate
-
Aljazeera HospitalSuez Canal UniversityUnknown
-
Ain Shams UniversityCompletedSecond Trimester AbortionEgypt
-
Dina Yahia MansourUnknown
-
Adrian HernandezMayo Clinic; National Heart, Lung, and Blood Institute (NHLBI); University of...CompletedHeart FailureUnited States
-
Cairo UniversityUnknownCervical RipeningEgypt
-
Abdelrahman Ali Fadel Youssef MohamedUnknownInduction of LaborEgypt
-
Assiut UniversityUnknownIUD Insertion Complication
-
Chinese PLA General HospitalUnknownCardio-Renal SyndromeChina
-
North Carolina State UniversityUniversity of North Carolina, Chapel Hill; U.S. National Science FoundationUnknownSpinal Cord Injuries | Paraplegia, Spinal | Paraplegia, IncompleteUnited States