Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01127581 · ClinicalTrials.gov registry record · Phase 3
Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery
A Phase 3 study of Cervical Ripening and Induction of Labor, sponsored by Ferring Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,358
- Enrollment target
- 20
- Study locations
NCT01127581: Completed Phase 3 study of Cervical Ripening and Induction of Labor, sponsored by Ferring Pharmaceuticals.
NCT01127581 is a Phase 3 study of Cervical Ripening and Induction of Labor that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 1,358 participants, above the 301-participant average among 8 other Cervical Ripening trials with a reported enrollment target (351% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01127581, a Phase 3 study of Cervical Ripening and Induction of Labor, has completed, sponsored by Ferring Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,358 participants
- Enrollment target
- 20
- Study locations
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 |
What the finished NCT01127581 record still lists
NCT01127581 is an interventional study that assigns participants to a tested intervention. Its 1,358 participants enrollment target places it among the larger protocols in the corpus, above the 301-participant average among 8 other Cervical Ripening trials with a reported enrollment target (351% higher).
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.
NCT01127581 names 20 study sites across 12 states, led by Arizona, Florida, California.
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.
What interventions are being tested in trial NCT01127581?
The interventions under investigation include: MVI 200 (DRUG), Dinoprostone Vaginal Insert (DVI) (DRUG).
Who is sponsoring clinical trial NCT01127581?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
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
Similar trials for Cervical Ripening
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01127581's enrollment target sits among peer trials
1,358 1st of 8 higher than 8 of 8 other Cervical Ripening trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cervical Ripening trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin
COMPLETED · Phase 3
-
Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor
COMPLETED · Phase 3
-
Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor
COMPLETED · NA
-
Foley Catheter Compared to the Foley Catheter Alone for Cervical Ripening
COMPLETED · NA
-
Misoprostol Vaginal Insert (MVI) 100, 150, 200 mcg for Cervical Ripening and Induction of Labor
COMPLETED · Phase 2
-
Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study)
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05245227 · 1,358 participants · Phase 3
Double Simultaneous Uterotonic Agents Versus Single Agent Regimen to Prevent Early Postpartum Hemorrhage
- NCT02677064 · 1,365 participants
Identify Barriers to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Newly Diagnosed and Relapsed Acute Leukemia
- NCT04489238 · 1,366 participants
Collection of Information to Better Understand Young Onset Colorectal Cancer
- NCT06318169 · 1,350 participants · Phase 3
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia