Trial of Cervical Ripening and Labor Induction Using Misoprostol With or Without Intravaginal Isosorbide Mononitrate
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ClinicalTrials.gov Identifier: NCT00374621 |
Recruitment Status :
Completed
First Posted : September 11, 2006
Last Update Posted : April 25, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Ripening | Drug: Misoprostol with or without isosorbide mononitrate | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 156 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Clinical Trial of Cervical Ripening and Labor Induction Using Stepwise Oral Misoprostol With or Without Intravaginal Isosorbide Mononitrate |
Study Start Date : | September 2006 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | January 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Misoprostol |
Drug: Misoprostol with or without 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 |
Active Comparator: Misoprostol with Isosorbide Mononitrate |
Drug: Misoprostol with or without 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 |
- Time to vaginal delivery [ Time Frame: First dose of study medication to delivery ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00374621
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Yasser Yehia El-Sayed | Stanford University |
Responsible Party: | Yasser Yehia El-Sayed, Professor, Stanford University |
ClinicalTrials.gov Identifier: | NCT00374621 |
Other Study ID Numbers: |
97274 |
First Posted: | September 11, 2006 Key Record Dates |
Last Update Posted: | April 25, 2017 |
Last Verified: | April 2017 |
Isosorbide Isosorbide Dinitrate Isosorbide-5-mononitrate Misoprostol Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Anti-Ulcer Agents |
Gastrointestinal Agents Oxytocics Diuretics, Osmotic Diuretics Natriuretic Agents Vasodilator Agents Nitric Oxide Donors Molecular Mechanisms of Pharmacological Action |