Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery
NCT01127581 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to determine whether the Misoprostol Vaginal Insert (MVI) 200 microgram (mcg) can decrease the time to vaginal delivery compared to the Dinoprostone Vaginal Insert (DVI) 10 milligram (mg) in pregnant women requiring cervical ripening and induction of labor.
Conditions Studied
Interventions
- DRUG MVI 200
- DRUG Dinoprostone Vaginal Insert (DVI)
Study Locations (20)
Arizona
- Maricopa Medical Center - District Medical Group — Phoenix
- Precision Trials — Phoenix
- Phoenix Perinatal Associates (Scottsdale Healthcare Shea) — Scottsdale
- Watching Over Mothers and Babies Foundation — Tucson
Florida
- University of FL College of Medicine — Jacksonville
- Altus Research — Lake Worth
- University of South Florida — Tampa
California
- Miller's Childrens Hospital — Long Beach
- UCI Medical Center — Orange
Michigan
- University of Michigan Hospital — Ann Arbor
- Spectrum Health — Grand Rapids
North Carolina
- Duke University Medical Center — Durham
- East Carolina University, Brody School of Medicine — Greenville
Colorado
- The Women's Clinic of Northern Colorado — Fort Collins
Delaware
- Christiana Care Health System (DE Center for MFM) — Newark
Indiana
- Indiana University School of Medicine — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,358 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-03 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01127581
The ClinicalTrials.gov registry entry for NCT01127581 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,358 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ferring Pharmaceuticals, which has 27 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Cervical Ripening appearing as the primary indexed condition, and to 2 interventions — of which MVI 200 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01127581 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Arizona, Florida, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01127581 about?
NCT01127581 is a clinical study titled "Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery". The purpose of this study is to determine whether the Misoprostol Vaginal Insert (MVI) 200 microgram (mcg) can decrease the time to vaginal delivery compared to the Dinoprostone Vaginal Insert (DVI) 10 milligram (mg) in pregnant women requiring cervical ripening and induction of labor.
What is the current status of trial NCT01127581?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,358 participants. The study started on 2010-09. Estimated completion is 2012-03.
What conditions does trial NCT01127581 study?
This clinical trial studies the following conditions: Cervical Ripening, Induction of Labor, Reducing Time to Vaginal Delivery. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01127581?
The interventions under investigation include: MVI 200 (DRUG), Dinoprostone Vaginal Insert (DVI) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01127581?
This trial is sponsored by Ferring Pharmaceuticals, which has 27 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01127581 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.