Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery (EXPEDITE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01127581 |
Recruitment Status :
Completed
First Posted : May 21, 2010
Results First Posted : March 7, 2014
Last Update Posted : May 1, 2014
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
Reducing Time to Vaginal Delivery Cervical Ripening Induction of Labor |
Interventions |
Drug: MVI 200 Drug: Dinoprostone Vaginal Insert (DVI) |
Enrollment | 1358 |
Recruitment Details | Pregnant women who required to be induced were recruited at 35 sites in the US. |
Pre-assignment Details |
Arm/Group Title | MVI 200 | Dinoprostone Vaginal Insert (DVI) |
---|---|---|
![]() |
MVI 200 mcg vaginal insert MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. |
10 mg Dinoprostone vaginal insert Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. |
Period Title: Overall Study | ||
Started | 678 | 680 |
Completed | 678 | 680 |
Not Completed | 0 | 0 |
Arm/Group Title | MVI 200 | Dinoprostone Vaginal Insert (DVI) | Total | |
---|---|---|---|---|
![]() |
MVI 200 mcg vaginal insert MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. |
10 mg Dinoprostone vaginal insert Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 678 | 680 | 1358 | |
![]() |
[Not Specified]
|
|||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 678 participants | 680 participants | 1358 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
678 100.0%
|
680 100.0%
|
1358 100.0%
|
|
>=65 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||
Number Analyzed | 678 participants | 680 participants | 1358 participants | |
26.2 (5.99) | 25.9 (5.95) | 26.0 (5.96) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 678 participants | 680 participants | 1358 participants | |
Female |
678 100.0%
|
680 100.0%
|
1358 100.0%
|
|
Male |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
||||
United States | Number Analyzed | 678 participants | 680 participants | 1358 participants |
678 | 680 | 1358 |
Name/Title: | Clinical Development Support |
Organization: | Ferring Pharmaceuticals |
EMail: | DK0-Disclosure@ferring.com |
Responsible Party: | Ferring Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01127581 |
Other Study ID Numbers: |
Miso-Obs-303 |
First Submitted: | May 19, 2010 |
First Posted: | May 21, 2010 |
Results First Submitted: | January 24, 2014 |
Results First Posted: | March 7, 2014 |
Last Update Posted: | May 1, 2014 |