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Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery (EXPEDITE)

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ClinicalTrials.gov Identifier: NCT01127581
Recruitment Status : Completed
First Posted : May 21, 2010
Results First Posted : March 7, 2014
Last Update Posted : May 1, 2014
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

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)
Hide Arm/Group Description

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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
[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
1.Primary Outcome
Title Time to Vaginal Delivery During the First Hospital Admission
Hide Description [Not Specified]
Time Frame Interval from study drug administration to vaginal delivery (average 24 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery, independent of treatment assignment. Subjects who were discharged prior to delivery or withdrew consent prior to delivery were also censored.
Arm/Group Title MVI 200 Dinoprostone Vaginal Insert (DVI)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 678 680
Median (95% Confidence Interval)
Unit of Measure: minutes
1292.00
(1200.00 to 1402.00)
1968.50
(1812.00 to 2093.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVI 200, Dinoprostone Vaginal Insert (DVI)
Comments Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -677
Estimation Comments Sample size 675 per group provides 90% power to see an improvement of ≥320 minutes (20% improvement from DVI) in time to vaginal delivery between MVI 200 & DVI assuming a median time of 1600 minutes for DVI & 34% dropout rate based on 5% 2‑sided test
2.Primary Outcome
Title Incidence of Cesarean Delivery During the First Hospital Admission
Hide Description [Not Specified]
Time Frame Interval from study drug administration to cesarean delivery (average 24 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on a between-treatment-group difference in the safety population. Subjects discharged prior to delivery, withdrew early without having a cesarean delivery or were lost-to-follow up were classified as not having the event.
Arm/Group Title MVI 200 Dinoprostone Vaginal Insert (DVI)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 678 680
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
25.96
(22.70 to 29.43)
27.06
(23.75 to 30.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVI 200, Dinoprostone Vaginal Insert (DVI)
Comments The analysis of the cesarean delivery rates during the first hospitalization was based on a between-treatment-group difference. If the upper limit of the asymptotic two-sided 95% confidence interval of the difference in event rates (MVI minus DVI) was less than the calculated non-inferiority margin (10% relative to the DVI rate, i.e., 0.1 times DVI rate), then MVI 200 would be considered non-inferior to DVI.
Type of Statistical Test Non-Inferiority or Equivalence
Comments A sample size of 675 subjects per group will provide a sufficient number of subjects to assess non-inferiority of MVI 200 with respect to rate of cesarean delivery, based on an alpha level of 5% and 80% power for a two-sided approach using a 10% non-inferiority limit (relative to the DVI rate), assuming a 30% rate of cesarean delivery in the DVI group compared to a 26% rate in the MVI 200 group.
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Populations
Estimated Value -1.10
Confidence Interval (2-Sided) 95%
-5.79 to 3.59
Estimation Comments MVI 200 - DVI
3.Secondary Outcome
Title Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission
Hide Description [Not Specified]
Time Frame Interval from study drug administration to neonate delivery (average 24 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who did not deliver during the first hospitalization were censored at the time of labour and delivery discharge.
Arm/Group Title MVI 200 Dinoprostone Vaginal Insert (DVI)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 678 680
Median (95% Confidence Interval)
Unit of Measure: minutes
1096.50
(1031.00 to 1170.00)
1639.50
(1573.00 to 1731.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVI 200, Dinoprostone Vaginal Insert (DVI)
Comments Subjects who did not deliver during the first hospitalization were censored using the longest time interval from study drug administration to labor and delivery discharge without delivery, independent of treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -543
Estimation Comments MVI 200 - DVI
4.Secondary Outcome
Title Time to Active Labor During the First Hospital Admission
Hide Description Active labor was defined as progressive cervical dilatation to 4 cm with any frequency of contractions OR rhythmic, firm, adequate quality uterine contractions causing progressive cervical change occurring at a frequency of 3 or more in 10 minutes and lasting 45 seconds or more.
Time Frame Interval from study drug administration to active labor (average 12 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population
Arm/Group Title MVI 200 Dinoprostone Vaginal Insert (DVI)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 678 680
Median (95% Confidence Interval)
Unit of Measure: minutes
726.50
(719.00 to 773.00)
1116.50
(1083.00 to 1352.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVI 200, Dinoprostone Vaginal Insert (DVI)
Comments Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery during the first hospitalization, independent of treatment group. Subjects who, in their first hospitalization, were discharged prior to delivery or withdrew consent prior to delivery were censored using the longest time interval from study drug administration to labor and delivery discharge, independent of treatment group.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value -390
Estimation Comments MVI 200 - DVI
5.Secondary Outcome
Title Incidence of Pre-delivery Oxytocin During the First Hospital Admission
Hide Description Percentage of participants in receipt of Oxytocin for induction after study drug removal.
Time Frame At least 30 minutes after study drug removal
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis population includes subjects who delivered during the first hospitalization.
Arm/Group Title MVI 200 Dinoprostone Vaginal Insert (DVI)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 674 671
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
48.1
(44.24 to 51.92)
74.1
(70.58 to 77.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVI 200, Dinoprostone Vaginal Insert (DVI)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value -26
Estimation Comments MVI 200 - DVI
6.Secondary Outcome
Title Incidence of Vaginal Delivery Within 12 Hours
Hide Description [Not Specified]
Time Frame Interval from study drug administration to vaginal delivery within 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) population
Arm/Group Title MVI 200 Dinoprostone Vaginal Insert (DVI)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 678 680
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
19.76
(16.83 to 22.96)
8.38
(6.41 to 10.72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVI 200, Dinoprostone Vaginal Insert (DVI)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 9.67
Estimation Comments MVI 200 - DVI
7.Secondary Outcome
Title Incidence of Any Delivery Within 24 Hours
Hide Description [Not Specified]
Time Frame Interval from study drug administration to delivery of neonate within 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) Population
Arm/Group Title MVI 200 Dinoprostone Vaginal Insert (DVI)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 678 680
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
67.70
(64.03 to 71.21)
40.74
(37.02 to 44.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVI 200, Dinoprostone Vaginal Insert (DVI)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 26.96
Estimation Comments MVI 200 - DVI
8.Secondary Outcome
Title Incidence of Any Delivery Within 12 Hours
Hide Description [Not Specified]
Time Frame Interval from study drug administration to delivery of neonate within 12 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) Population
Arm/Group Title MVI 200 Dinoprostone Vaginal Insert (DVI)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 678 680
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.16
(20.03 to 26.52)
9.26
(7.19 to 11.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVI 200, Dinoprostone Vaginal Insert (DVI)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 13.90
Estimation Comments MVI 200 - DVI
9.Secondary Outcome
Title Incidence of Vaginal Delivery Within 24 Hours
Hide Description [Not Specified]
Time Frame Interval from study drug administration to vaginal delivery within 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT) Population
Arm/Group Title MVI 200 Dinoprostone Vaginal Insert (DVI)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 678 680
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.57
(50.74 to 58.37)
33.97
(30.41 to 37.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVI 200, Dinoprostone Vaginal Insert (DVI)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 29.80
Estimation Comments MVI 200 - DVI
10.Secondary Outcome
Title Incidence of Vaginal Delivery
Hide Description [Not Specified]
Time Frame Interval from study drug administration to vaginal delivery (average 24 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
The Intention-to-Treat (ITT) population was used for all secondary efficacy analyses.
Arm/Group Title MVI 200 Dinoprostone Vaginal Insert (DVI)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 678 680
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
73.30
(69.80 to 76.60)
71.62
(68.07 to 74.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection MVI 200, Dinoprostone Vaginal Insert (DVI)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Proportions
Estimated Value 1.68
Estimation Comments MVI 200 - DVI
11.Secondary Outcome
Title Rate of Adverse Events
Hide Description All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug.
Time Frame From study drug administration to hospital discharge (approximately 48-72 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
The percentage of subjects with adverse events are presented for the Intrapartum (before delivery), postpartum (maternal) and neonatal periods.
Arm/Group Title MVI 200 Dinoprostone Vaginal Insert (DVI)
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 678 680
Measure Type: Number
Unit of Measure: percentage of participants
Subjects with an Intrapartum Adverse Events 55.5 54.6
Subjects with Maternal Postpartum Adverse Events 21.4 21.2
Subjects with Neonatal Adverse Events 53.4 58.1
Time Frame All adverse events were followed until resolution or at least 30 days after discontinuation of the study drug, whichever occurred first.
Adverse Event Reporting Description All adverse events occurring to the maternal-fetal unit (pre-delivery/ intrapartum), the mother (postpartum) or the neonate were recorded. Adverse events that resulted in a cesarean delivery were reported as serious adverse events as they were medically significant events that routinely prolonged the duration of hospitalization.
 
Arm/Group Title MVI 200 Dinoprostone Vaginal Insert (DVI)
Hide Arm/Group Description

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.

All-Cause Mortality
MVI 200 Dinoprostone Vaginal Insert (DVI)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
MVI 200 Dinoprostone Vaginal Insert (DVI)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   130/678 (19.17%)      107/680 (15.74%)    
Blood and lymphatic system disorders     
Disseminated intravascular coagulation #  1 [1]  1/678 (0.15%)  1 0/680 (0.00%)  0
Polycythaemia *  1 [2]  1/678 (0.15%)  1 0/680 (0.00%)  0
Cardiac disorders     
Pericarditis #  1 [1]  0/678 (0.00%)  0 1/680 (0.15%)  1
Supraventricular tachycardia *  1 [2]  1/678 (0.15%)  1 0/680 (0.00%)  0
Supraventricular tachycardia +  1 [3]  0/678 (0.00%)  0 1/680 (0.15%)  1
Congenital, familial and genetic disorders     
Adrenogenital syndrome *  1 [2]  1/678 (0.15%)  1 0/680 (0.00%)  0
Anal atresia *  1 [2]  0/678 (0.00%)  0 1/680 (0.15%)  1
Ankyloglossia congenital *  1 [2]  3/678 (0.44%)  3 2/680 (0.29%)  2
Anomalous pulmonary venous connection *  1 [2]  1/678 (0.15%)  1 0/680 (0.00%)  0
Atrial septal defect *  1 [2]  8/678 (1.18%)  8 6/680 (0.88%)  6
Cataract congenital *  1 [2]  0/678 (0.00%)  0 1/680 (0.15%)  1
Congenital choroid plexus cyst *  1 [2]  1/678 (0.15%)  1 0/680 (0.00%)  0
Congenital hydronephrosis *  1 [2]  0/678 (0.00%)  0 1/680 (0.15%)  1
Congenital nose malformation *  1 [2]  0/678 (0.00%)  0 1/680 (0.15%)  1
Congenital pyelocaliectasis *  1 [2]  1/678 (0.15%)  1 1/680 (0.15%)  1
Cryptorchism *  1 [2]  6/678 (0.88%)  6 2/680 (0.29%)  2
Hydrocele *  1 [2]  1/678 (0.15%)  1 1/680 (0.15%)  1
Hypospadias *  1 [2]  4/678 (0.59%)  4 4/680 (0.59%)  4
Patent ductus arteriosus *  1 [2]  4/678 (0.59%)  4 4/680 (0.59%)  4
Penile torsion *  1 [2]  3/678 (0.44%)  3 1/680 (0.15%)  1
Phimosis *  1 [2]  0/678 (0.00%)  0 3/680 (0.44%)  3
Pilonidal cyst congenital *  1 [2]  3/678 (0.44%)  3 7/680 (1.03%)  7
Polydactyly *  1 [2]  3/678 (0.44%)  3 3/680 (0.44%)  3
Pulmonary artery stenosis congenital *  1 [2]  1/678 (0.15%)  1 0/680 (0.00%)  0
Supernumerary nipple *  1 [2]  0/678 (0.00%)  0 2/680 (0.29%)  2
Syndactyly *  1 [2]  1/678 (0.15%)  1 0/680 (0.00%)  0
Talipes *  1 [2]  1/678 (0.15%)  1 0/680 (0.00%)  0
VACTERL syndrome *  1 [2]  2/678 (0.29%)  2 0/680 (0.00%)  0
Ventricular septal defect *  1 [2]  4/678 (0.59%)  4 1/680 (0.15%)  1
Eye disorders     
Vitreous haemorrhage *  1 [2]  0/678 (0.00%)  0 1/680 (0.15%)  1
Gastrointestinal disorders     
Anal fistula *  1 [2]  0/678 (0.00%)  0 1/680 (0.15%)  1
Intestinal obstruction *  1 [2]  1/678 (0.15%)  1 0/680 (0.00%)  0
Salivary gland enlargement *  1 [2]  1/678 (0.15%)  1 0/680 (0.00%)  0
General disorders     
Fever neonatal *  1 [2]  1/678 (0.15%)  1 0/680 (0.00%)  0
Infections and infestations     
Endometritis #  1 [1]  2/678 (0.29%)  2 1/680 (0.15%)  1
Pneumonia *  1 [2]  0/678 (0.00%)  0 1/680 (0.15%)  1
Pneumonia #  1 [1]  0/678 (0.00%)  0 1/680 (0.15%)  1
Postpartum sepsis #  1 [1]  1/678 (0.15%)  1 0/680 (0.00%)  0
Sepsis neonatal *  1 [2]  1/678 (0.15%)  1 1/680 (0.15%)  1
Septic shock *  1 [2]  0/678 (0.00%)  0 1/680 (0.15%)  1
Injury, poisoning and procedural complications     
Skull fracture *  1 [2]  1/678 (0.15%)  1 0/680 (0.00%)  0
Investigations     
Urine output decreased *  1 [2]  1/678 (0.15%)  1 1/680 (0.15%)  1
Metabolism and nutrition disorders     
Feeding disorder neonatal *  1 [2]  1/678 (0.15%)  1 2/680 (0.29%)  2
Musculoskeletal and connective tissue disorders     
Joint crepitation *  1 [2]  1/678 (0.15%)  1 1/680 (0.15%)  1
Muscular weakness #  1 [1]  0/678 (0.00%)  0 1/680 (0.15%)  1
Nervous system disorders     
Dysaesthesia #  1 [1]  1/678 (0.15%)  1 0/680 (0.00%)  0
Encephalopathy neonatal *  1 [2]  0/678 (0.00%)  0 1/680 (0.15%)  1
Hypoxic-ischaemic encephalopathy *  1 [2]  4/678 (0.59%)  4 0/680 (0.00%)  0
Paraesthesia #  1 [1]  0/678 (0.00%)  0 1/680 (0.15%)  1
Pregnancy, puerperium and perinatal conditions     
Abnormal labour affecting foetus +  1 [3]  13/678 (1.92%)  13 0/680 (0.00%)  0
Drug withdrawal syndrome neonatal *  1 [2]  1/678 (0.15%)  1 1/680 (0.15%)  1
Erb's palsy *  1 [2]  0/678 (0.00%)  0 1/680 (0.15%)  1
Foetal acidosis *  1 [2]  1/678 (0.15%)  1 0/680 (0.00%)  0
Foetal heart rate disorder +  1 [3]  65/678 (9.59%)  65 46/680 (6.76%)  46
Hypoglycaemia neonatal *  1 [2]  3/678 (0.44%)  3 2/680 (0.29%)  2
Neonatal disorder *  1 [2]  1/678 (0.15%)  1 0/680 (0.00%)  0
Postpartum haemorrhage #  1 [1]  2/678 (0.29%)  2 3/680 (0.44%)  3
Premature separation of placenta +  1 [3]  1/678 (0.15%)  1 0/680 (0.00%)  0
Puerperal pyrexia #  1 [1]  1/678 (0.15%)  1 0/680 (0.00%)  0
Retained placenta or membranes #  1 [1]  0/678 (0.00%)  0 1/680 (0.15%)  1
Uterine contractions abnormal +  1 [3]  1/678 (0.15%)  1 0/680 (0.00%)  0
Uterine rupture +  1 [3]  1/678 (0.15%)  1 0/680 (0.00%)  0
Weight decrease neonatal *  1 [2]  1/678 (0.15%)  1 1/680 (0.15%)  1
Psychiatric disorders     
Anxiety #  1 [1]  0/678 (0.00%)  0 1/680 (0.15%)  1
Renal and urinary disorders     
Hydronephrosis *  1 [2]  0/678 (0.00%)  0 1/680 (0.15%)  1
Reproductive system and breast disorders     
Chordee *  1 [2]  1/678 (0.15%)  1 0/680 (0.00%)  0
Testicular torsion *  1 [2]  0/678 (0.00%)  0 1/680 (0.15%)  1
Vulval haematoma #  1 [1]  0/678 (0.00%)  0 1/680 (0.15%)  1
Respiratory, thoracic and mediastinal disorders     
Neonatal aspiration *  1 [2]  1/678 (0.15%)  1 2/680 (0.29%)  2
Neonatal respiratory depression *  1 [2]  0/678 (0.00%)  0 1/680 (0.15%)  1
Neonatal respiratory distress syndrome *  1 [2]  0/678 (0.00%)  0 1/680 (0.15%)  1
Pneumothorax *  1 [2]  0/678 (0.00%)  0 1/680 (0.15%)  1
Transient tachypnoea of the newborn *  1 [2]  1/678 (0.15%)  1 0/680 (0.00%)  0
Vascular disorders     
Deep vein thrombosis #  1 [1]  1/678 (0.15%)  1 0/680 (0.00%)  0
Hypertension #  1 [1]  1/678 (0.15%)  1 1/680 (0.15%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
[1]
# Postpartum Event
[2]
* Neonatal Event
[3]
+ Intrapartum Event
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MVI 200 Dinoprostone Vaginal Insert (DVI)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   520/678 (76.70%)      533/680 (78.38%)    
Pregnancy, puerperium and perinatal conditions     
Abnormal labour affecting foetus +  1 [1]  59/678 (8.70%)  62 19/680 (2.79%)  19
Arrested labour +  1 [1]  96/678 (14.16%)  96 128/680 (18.82%)  129
Caput succedaneum *  1 [2]  58/678 (8.55%)  58 60/680 (8.82%)  60
Chorioamnionitis +  1 [1]  38/678 (5.60%)  38 59/680 (8.68%)  59
Foetal heart rate disorder +  1 [1]  124/678 (18.29%)  138 138/680 (20.29%)  160
Hyperbilirubinaemia neonatal *  1 [2]  62/678 (9.14%)  62 78/680 (11.47%)  78
Meconium in amniotic fluid +  1 [1]  120/678 (17.70%)  120 92/680 (13.53%)  92
Postpartum haemorrhage #  1 [3]  40/678 (5.90%)  41 37/680 (5.44%)  37
Umbilical cord around neck *  1 [2]  184/678 (27.14%)  184 194/680 (28.53%)  194
Respiratory, thoracic and mediastinal disorders     
Neonatal respiratory depression *  1 [2]  34/678 (5.01%)  34 30/680 (4.41%)  30
Surgical and medical procedures     
Infection prophylaxis *  1 [2]  46/678 (6.78%)  46 63/680 (9.26%)  63
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.1)
[1]
+ Intrapartum Event
[2]
* Neonatal Event
[3]
# Postpartum Event
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Any abstract,presentation or manuscript proposed for publication must be submitted to the Sponsor for review at least 30 days prior to submission for any meeting or journal.If deemed necessary by the Sponsor for protection of proprietary information prior to patent filing,the Investigator agrees to a further delay of 60 days before any presentation or publication is submitted.Publications must be in a form that does not reveal technical information that is considered confidential or proprietary.
Results Point of Contact
Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01127581     History of Changes
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