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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 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.

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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.

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

FieldValue
Enrollment Target 1,358 participants
Start Date 2010-09
Est. Completion 2012-03
Phase Phase 3

Sponsor

Ferring Pharmaceuticals

83 total trials

What the Registry Record Tells You About NCT01127581

The ClinicalTrials.gov registry entry for NCT01127581 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,358 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 301-participant average among 8 other Cervical Ripening trials with a reported enrollment target (351% higher). The listed sponsor is Ferring Pharmaceuticals, which has 83 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.