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Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor

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ClinicalTrials.gov Identifier: NCT00308711
Recruitment Status : Completed
First Posted : March 30, 2006
Results First Posted : February 19, 2010
Last Update Posted : June 25, 2012
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 Cervical Ripening
Labor, Induced
Interventions Drug: Misoprostol vaginal insert 100 mcg
Drug: Misoprostol vaginal insert 50 mcg
Drug: Dinoprostone vaginal insert (Cervidil)
Enrollment 1308
Recruitment Details First subject entered 26 April 2006; last subject completed 07 August 2007; 49 hospitals entered subjects requiring cervical ripening prior to induction of labor.
Pre-assignment Details  
Arm/Group Title Misoprostol Vaginal Insert (MVI) 100 Misoprostol Vaginal Insert (MVI) 50 Cervidil 10 mg Vaginal Insert
Hide Arm/Group Description Misoprostol vaginal insert 100 mcg over a period of up to 24 h Misoprostol vaginal insert 50 mcg over a period of up to 24 h Cervidil 10 mg vaginal insert over a period of up to 24h
Period Title: Overall Study
Started 428 444 436
Completed 426 440 431
Not Completed 2 4 5
Reason Not Completed
Withdrawal by Subject             1             0             1
Protocol Violation             0             1             1
Lost to Follow-up             0             1             0
Baby not born within 7 days of treatment             1             2             2
Subject incarcerated, data not allowed             0             0             1
Arm/Group Title Misoprostol Vaginal Insert (MVI) 100 Misoprostol Vaginal Insert (MVI) 50 Cervidil 10 mg Vaginal Insert Total
Hide Arm/Group Description Misoprostol vaginal insert 100 mcg over a period of up to 24 h Misoprostol vaginal insert 50 mcg over a period of up to 24 h Cervidil 10 mg vaginal insert over a period of up to 24h Total of all reporting groups
Overall Number of Baseline Participants 428 444 436 1308
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 428 participants 444 participants 436 participants 1308 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
428
 100.0%
444
 100.0%
436
 100.0%
1308
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 428 participants 444 participants 436 participants 1308 participants
26.2  (5.9) 26.9  (6.2) 26.0  (5.7) 26.4  (5.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 428 participants 444 participants 436 participants 1308 participants
Female
428
 100.0%
444
 100.0%
436
 100.0%
1308
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 428 participants 444 participants 436 participants 1308 participants
United States 413 427 419 1259
Canada 15 17 17 49
Parity   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 428 participants 444 participants 436 participants 1308 participants
Nulliparous 267 275 270 812
Parous 161 169 166 496
[1]
Measure Description: Nulliparaous = no previous vaginal delivery prior to 24 wks gestation Parous = at least one previous vaginal delivery after 24 weeks
modified Bishop score (mBS)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale of 0 (low) to 12 (most)
Number Analyzed 428 participants 444 participants 436 participants 1308 participants
2.69  (1.1) 2.74  (1.1) 2.73  (1.1) 2.72  (1.1)
[1]
Measure Description: The mBS measures cervical softness. There are five elements assessed during a vaginal examination. Maximum mBS is 12: 0 to 3 for Dilation, 0 to 3 for Station, 0 to 2 for Consistency, 0 to 1 for Position, and 0 to 3 for Length of Cervix. A score of zero is a long, closed, thick firm cervix; a score of 12 indicates thin, completely soft, 100% effaced cervix.
1.Primary Outcome
Title Minutes From Drug Insertion to Vaginal Delivery
Hide Description Interval between time/date of insertion of study drug and time/date of neonate birth. This is a time-to-event analysis, there is no set time for the assessment. The endpoint occurs when the baby is born. 48 hours can be used as an approximate interval by which time most of the babies have been delivered.
Time Frame 2880 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis is for time to vaginal delivery (interval from insertion of study drug into the vagina to the delivery of the neonate); patients delivered by cesarean section were censored from this time-to-event analysis using the longest interval for all participants from insertion of study drug to cesarean section delivery of neonate.
Arm/Group Title Misoprostol Vaginal Insert (MVI) 100 Misoprostol Vaginal Insert (MVI) 50 Cervidil 10 mg Vaginal Insert
Hide Arm/Group Description:
Misoprostol vaginal insert 100 mcg over a period of up to 24 h
Misoprostol vaginal insert 50 mcg over a period of up to 24 h
Cervidil 10 mg vaginal insert over a period of up to 24h
Overall Number of Participants Analyzed 426 440 431
Median (95% Confidence Interval)
Unit of Measure: minutes
1595.5
(1469 to 1739)
2127
(1977 to 2253)
1649.5
(1509 to 1824)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Misoprostol Vaginal Insert (MVI) 100, Cervidil 10 mg Vaginal Insert
Comments Null hypothesis was that there would be no difference in time to vaginal delivery for MVI 100 compared to time to vaginal delivery for Cervidil.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.974
Comments The a priori threshold for statistical significance was 0.05.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Kaplan-Meier
Estimated Value 1595.5
Estimation Comments This was a Kaplan-Meier analysis of median time to vaginal delivery. Cervidil was compared separately to MVI 100 and MVI 50.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Misoprostol Vaginal Insert (MVI) 50, Cervidil 10 mg Vaginal Insert
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1977
Confidence Interval 95%
1977 to 2253
Estimation Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants With a Cesarean Section Delivery
Hide Description Percentage of participants with cesarean delivery after study drug was administered. There is no set assessment time or date as the woman's labor may last hours or days.
Time Frame 2880 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Misoprostol Vaginal Insert (MVI) 100 Misoprostol Vaginal Insert (MVI) 50 Cervidil 10 mg Vaginal Insert
Hide Arm/Group Description:
Misoprostol vaginal insert 100 mcg over a period of up to 24 h
Misoprostol vaginal insert 50 mcg over a period of up to 24 h
Cervidil 10 mg vaginal insert over a period of up to 24h
Overall Number of Participants Analyzed 426 440 431
Measure Type: Number
Unit of Measure: Percentage of participants
28 28 26
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Misoprostol Vaginal Insert (MVI) 100, Cervidil 10 mg Vaginal Insert
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority (NI) margin was within 15% relative to the rate of cesarean section for the comparator (Cervidil 10 mg dinoprostone vaginal insert).
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 27.8
Confidence Interval 95%
23.61 to 32.31
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Misoprostol Vaginal Insert (MVI) 50, Cervidil 10 mg Vaginal Insert
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority margin was rate of cearean section within 15% of Cervidil rate.
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 28.0
Confidence Interval 95%
23.86 to 32.42
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events
Hide Description This outcome reports the percentage of adverse events in each treatment arm spontaneously reported or observed during the study. The intrapartum period (mother is still pregnant) is called the "Maternal/Fetal" period; once the baby has been born, adverse events are assessed separately for the mother (Post Partum) and the baby (Neonatal). The number of adverse events was assessed separately for each of the three periods.
Time Frame 96 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Analysis was based on intention to treat, i.e., all subjects who had the insert placed in the vagina.
Arm/Group Title Misoprostol Vaginal Insert (MVI) 100 Misoprostol Vaginal Insert (MVI) 50 Cervidil 10 mg Vaginal Insert
Hide Arm/Group Description:
Misoprostol vaginal insert 100 mcg over a period of up to 24 h
Misoprostol vaginal insert 50 mcg over a period of up to 24 h
Cervidil 10 mg vaginal insert over a period of up to 24h
Overall Number of Participants Analyzed 426 440 431
Measure Type: Number
Unit of Measure: Percentage of participants
Maternal/Fetal 65 64 65
Maternal (Post-Partum) 29 26 27
Neonatal 29 24 27
4.Secondary Outcome
Title Percentage of Participants With Pre-Delivery Oxytocin Use
Hide Description Incidence in each treatment group of need for oxytocin for pre-delivery induction or augmentation of labor.
Time Frame 2880 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
This analysis included all participants exposed to study drug and for whom there was data available regarding whether oxytocin was used pre-delivery.
Arm/Group Title Misoprostol Vaginal Insert (MVI) 100 Misoprostol Vaginal Insert (MVI) 50 Cervidil 10 mg Vaginal Insert
Hide Arm/Group Description:
Misoprostol vaginal insert 100 mcg over a period of up to 24 h
Misoprostol vaginal insert 50 mcg over a period of up to 24 h
Cervidil 10 mg vaginal insert over a period of up to 24h
Overall Number of Participants Analyzed 426 440 431
Measure Type: Number
Unit of Measure: Percentage of participants
68.5 80.8 69.0
5.Secondary Outcome
Title Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert
Hide Description Measured the percentage of participants who achieved success on the mBS. This composite score is based on the mBS and vaginal delivery and it is measured 12 hours after insertion of the study drug. The mBS has a score of 0 when the cervix is not ripe and a score of 12 when completely ripened. The 12 hour score is compared to baseline. Using the mBS, assess at 12 hours whether each subject has met any of the following three criteria: 1) has improved (increased) the mBS by at least 3 points from baseline; 2) has reached a score of at least 6 on the mBS; or 3) has acheived a vaginal delivery.
Time Frame 12 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Misoprostol Vaginal Insert (MVI) 100 Misoprostol Vaginal Insert (MVI) 50 Cervidil 10 mg Vaginal Insert
Hide Arm/Group Description:
Misoprostol vaginal insert 100 mcg over a period of up to 24 h
Misoprostol vaginal insert 50 mcg over a period of up to 24 h
Cervidil 10 mg vaginal insert over a period of up to 24h
Overall Number of Participants Analyzed 426 440 431
Measure Type: Number
Unit of Measure: Percentage of Participants
59 50 60
6.Secondary Outcome
Title Minutes to Onset of Active Labor
Hide Description Interval from insertion of study drug to onset of active labor, defined as at least three contractions in a ten-minute period of at least moderate intensity and resulting in cervical change such as dilatation or effacement; OR at least 4 cm cervical dilatation achieved after progressive change in dilatation.
Time Frame 2880 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Misoprostol Vaginal Insert (MVI) 100 Misoprostol Vaginal Insert (MVI) 50 Cervidil 10 mg Vaginal Insert
Hide Arm/Group Description:
Misoprostol vaginal insert 100 mcg over a period of up to 24 h
Misoprostol vaginal insert 50 mcg over a period of up to 24 h
Cervidil 10 mg vaginal insert over a period of up to 24h
Overall Number of Participants Analyzed 426 440 431
Mean (Standard Deviation)
Unit of Measure: minutes
1032.5  (627.2) 1343.7  (692.0) 1005.2  (667.1)
7.Secondary Outcome
Title Minutes to Rupture of Membranes (ROM)
Hide Description Interval from study drug insertion to ROM.
Time Frame 2880 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Misoprostol Vaginal Insert (MVI) 100 Misoprostol Vaginal Insert (MVI) 50 Cervidil 10 mg Vaginal Insert
Hide Arm/Group Description:
Misoprostol vaginal insert 100 mcg over a period of up to 24 h
Misoprostol vaginal insert 50 mcg over a period of up to 24 h
Cervidil 10 mg vaginal insert over a period of up to 24h
Overall Number of Participants Analyzed 426 440 431
Median (95% Confidence Interval)
Unit of Measure: minutes
1285.0
(906.0 to 2208.0)
1364.0
(1048 to 2491)
1123
(915 to 1580)
8.Secondary Outcome
Title Duration of Stay in Minutes in Labor and Delivery Suite
Hide Description Minutes in Labor and Delivery (L & D) suite starting from insertion of the study drug to discharge from L & D to post partum care.
Time Frame 5760 minuts
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Misoprostol Vaginal Insert (MVI) 100 Misoprostol Vaginal Insert (MVI) 50 Cervidil 10 mg Vaginal Insert
Hide Arm/Group Description:
Misoprostol vaginal insert 100 mcg over a period of up to 24 h
Misoprostol vaginal insert 50 mcg over a period of up to 24 h
Cervidil 10 mg vaginal insert over a period of up to 24h
Overall Number of Participants Analyzed 426 440 431
Mean (Standard Deviation)
Unit of Measure: minutes
1683.6  (811) 2010  (850) 1729  (862)
9.Secondary Outcome
Title Days in Hospital for Mother and Neonate
Hide Description Duration of stay in hospital for mother and neonate starting with insertion of the study drug and ending with discharge from the hospital.
Time Frame 10 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Misoprostol Vaginal Insert (MVI) 100 Misoprostol Vaginal Insert (MVI) 50 Cervidil 10 mg Vaginal Insert
Hide Arm/Group Description:
Misoprostol vaginal insert 100 mcg over a period of up to 24 h
Misoprostol vaginal insert 50 mcg over a period of up to 24 h
Cervidil 10 mg vaginal insert over a period of up to 24h
Overall Number of Participants Analyzed 426 440 431
Mean (Standard Deviation)
Unit of Measure: days
Mother 4.5  (1.24) 4.7  (1.1) 4.5  (1.3)
Neonate 3.6  (1.8) 3.5  (1.2) 3.6  (1.6)
Time Frame 96 hours
Adverse Event Reporting Description Adverse event data were collected during the hospital period only. One subject in the MVI 50 group was incarcerated; her information was not permitted to be used for data analysis, therefore all results are based on 443 subjects for this treatment groups.
 
Arm/Group Title Misoprostol Vaginal Insert (MVI) 100 Misoprostol Vaginal Insert (MVI) 50 Cervidil 10 mg Vaginal Insert
Hide Arm/Group Description Misoprostol vaginal insert 100 mcg over a period of up to 24 h Misoprostol vaginal insert 50 mcg over a period of up to 24 h Cervidil 10 mg vaginal insert over a period of up to 24h
All-Cause Mortality
Misoprostol Vaginal Insert (MVI) 100 Misoprostol Vaginal Insert (MVI) 50 Cervidil 10 mg Vaginal Insert
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Misoprostol Vaginal Insert (MVI) 100 Misoprostol Vaginal Insert (MVI) 50 Cervidil 10 mg Vaginal Insert
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   106/428 (24.77%)      134/443 (30.25%)      117/436 (26.83%)    
Blood and lymphatic system disorders       
Thrombocytopenia * 1  1/428 (0.23%)  1 0/443 (0.00%)  0 0/436 (0.00%)  0
Anaemia * 1  0/428 (0.00%)  0 1/443 (0.23%)  1 0/436 (0.00%)  0
polycythaemia * 1  0/428 (0.00%)  0 0/443 (0.00%)  0 1/436 (0.23%)  1
Cardiac disorders       
Wolff-Parkinson-White Syndrome * 1  0/428 (0.00%)  0 1/443 (0.23%)  1 0/436 (0.00%)  0
Cardiac Failure Congestive * 1  3/428 (0.70%)  3 2/443 (0.45%)  2 1/436 (0.23%)  1
congestive cardiomyopathy * 1  1/428 (0.23%)  1 0/443 (0.00%)  0 0/436 (0.00%)  0
Tachycardia * 1  1/428 (0.23%)  1 0/443 (0.00%)  0 0/436 (0.00%)  0
Chest pain * 1  2/428 (0.47%)  2 0/443 (0.00%)  0 1/436 (0.23%)  1
bradycardia neonatal * 1  1/428 (0.23%)  1 0/443 (0.00%)  0 1/436 (0.23%)  1
tachcardia foetal * 1  0/428 (0.00%)  0 0/443 (0.00%)  0 1/436 (0.23%)  1
Congenital, familial and genetic disorders       
congenital anomaly * 1  10/428 (2.34%)  10 7/443 (1.58%)  7 7/436 (1.61%)  7
Gastrointestinal disorders       
Ileus * 1  0/428 (0.00%)  0 0/443 (0.00%)  0 1/436 (0.23%)  1
General disorders       
Pyrexia * 1  1/428 (0.23%)  1 0/443 (0.00%)  0 1/436 (0.23%)  1
Neonatal hypothermia * 1  0/428 (0.00%)  0 1/443 (0.23%)  1 0/436 (0.00%)  0
Hepatobiliary disorders       
Liver abscess * 1  0/428 (0.00%)  0 1/443 (0.23%)  1 0/436 (0.00%)  0
hyperbilirubinemia neonatal * 1  6/428 (1.40%)  6 5/443 (1.13%)  5 8/436 (1.83%)  8
Infections and infestations       
Herpes Simplex * 1  1/428 (0.23%)  1 0/443 (0.00%)  0 0/436 (0.00%)  0
Endometritis * 1  2/428 (0.47%)  2 2/443 (0.45%)  2 3/436 (0.69%)  3
cellulitis * 1  1/428 (0.23%)  1 0/443 (0.00%)  0 0/436 (0.00%)  0
pyelonephritis * 1  0/428 (0.00%)  0 0/443 (0.00%)  0 2/436 (0.46%)  2
wound infection * 1  1/428 (0.23%)  1 0/443 (0.00%)  0 1/436 (0.23%)  1
Group B sepsis neonatal * 1  0/428 (0.00%)  0 0/443 (0.00%)  0 1/436 (0.23%)  1
sepsis * 1  1/428 (0.23%)  1 0/443 (0.00%)  0 1/436 (0.23%)  1
Investigations       
urine output decreased * 1  1/428 (0.23%)  1 0/443 (0.00%)  0 0/436 (0.00%)  0
Apgar score low * 1  4/428 (0.93%)  4 2/443 (0.45%)  2 2/436 (0.46%)  2
Nervous system disorders       
peroneal nerve palsy * 1  0/428 (0.00%)  0 0/443 (0.00%)  0 1/436 (0.23%)  1
Pregnancy, puerperium and perinatal conditions       
Arrested Labor * 1 [1]  25/428 (5.84%)  25 36/443 (8.13%)  36 33/436 (7.57%)  33
Cephalopelvic Disproportion * 1  14/428 (3.27%)  14 35/443 (7.90%)  35 29/436 (6.65%)  29
Abnormal Labor Affecting Fetus * 1  2/428 (0.47%)  2 0/443 (0.00%)  0 0/436 (0.00%)  0
Chorioamnionitis * 1  0/428 (0.00%)  0 4/443 (0.90%)  4 0/436 (0.00%)  0
Foetal heart rate disorder * 1  46/428 (10.75%)  46 47/443 (10.61%)  47 35/436 (8.03%)  35
Foetal malpresentation * 1  4/428 (0.93%)  4 3/443 (0.68%)  3 6/436 (1.38%)  6
Pregnancy-induced hypertension * 1  0/428 (0.00%)  0 0/443 (0.00%)  0 1/436 (0.23%)  1
Premature separation of placenta * 1  1/428 (0.23%)  1 0/443 (0.00%)  0 0/436 (0.00%)  0
umbilical cord prolapse * 1  0/428 (0.00%)  0 0/443 (0.00%)  0 5/436 (1.15%)  5
uterine contractions abnormal * 1  1/428 (0.23%)  1 1/443 (0.23%)  1 0/436 (0.00%)  0
uterine hypertonus * 1  0/428 (0.00%)  0 1/443 (0.23%)  1 0/436 (0.00%)  0
postpartum hemorrhage * 1  1/428 (0.23%)  1 4/443 (0.90%)  4 4/436 (0.92%)  4
preeclampsia * 1  0/428 (0.00%)  0 0/443 (0.00%)  0 1/436 (0.23%)  1
ABO hemolytic disease of the newborn * 1  9/428 (2.10%)  9 8/443 (1.81%)  9 3/436 (0.69%)  3
cephalohaematoma * 1  0/428 (0.00%)  0 1/443 (0.23%)  1 0/436 (0.00%)  0
jaundice * 1  2/428 (0.47%)  2 2/443 (0.45%)  2 1/436 (0.23%)  1
Renal and urinary disorders       
nephrolithiasis * 1  0/428 (0.00%)  0 0/443 (0.00%)  0 2/436 (0.46%)  2
urinary retention * 1  0/428 (0.00%)  0 0/443 (0.00%)  0 1/436 (0.23%)  1
Reproductive system and breast disorders       
uterine atony * 1  1/428 (0.23%)  1 0/443 (0.00%)  0 1/436 (0.23%)  1
Respiratory, thoracic and mediastinal disorders       
Pulmonary oedema * 1  0/428 (0.00%)  0 0/443 (0.00%)  0 1/436 (0.23%)  1
dyspnoea * 1  2/428 (0.47%)  2 2/443 (0.45%)  2 0/436 (0.00%)  0
pleuritic pain * 1  0/428 (0.00%)  0 1/443 (0.23%)  1 0/436 (0.00%)  0
pulmonary embolism * 1  1/428 (0.23%)  1 0/443 (0.00%)  0 0/436 (0.00%)  0
neonatal aspiration * 1  2/428 (0.47%)  2 1/443 (0.23%)  1 4/436 (0.92%)  4
neonatal respiratory depression * 1  5/428 (1.17%)  5 1/443 (0.23%)  1 5/436 (1.15%)  5
neonatal respiratory distress syndrome * 1  2/428 (0.47%)  2 3/443 (0.68%)  3 4/436 (0.92%)  4
transient tachypnea of the newborn * 1  1/428 (0.23%)  1 1/443 (0.23%)  1 4/436 (0.92%)  4
Surgical and medical procedures       
infection prophylaxis * 1  2/428 (0.47%)  2 3/443 (0.68%)  3 2/436 (0.46%)  2
Vascular disorders       
hypertension * 1  2/428 (0.47%)  2 0/443 (0.00%)  0 0/436 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (6.1)
[1]
Also included terms such as Failure to progress
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.0%
Misoprostol Vaginal Insert (MVI) 100 Misoprostol Vaginal Insert (MVI) 50 Cervidil 10 mg Vaginal Insert
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   130/428 (30.37%)      129/443 (29.12%)      132/436 (30.28%)    
Blood and lymphatic system disorders       
Anemia * 1  21/428 (4.91%)  21 25/443 (5.64%)  25 20/436 (4.59%)  20
Hepatobiliary disorders       
neonatal hyperbilirubinemia * 1  9/428 (2.10%)  9 6/443 (1.35%)  6 15/436 (3.44%)  15
Investigations       
Apgar score low * 1  10/428 (2.34%)  10 10/443 (2.26%)  10 10/436 (2.29%)  10
Pregnancy, puerperium and perinatal conditions       
Abnormal labour affecting foetus * 1  24/428 (5.61%)  24 12/443 (2.71%)  12 28/436 (6.42%)  28
Chorioamnionitis * 1  17/428 (3.97%)  17 30/443 (6.77%)  30 22/436 (5.05%)  22
Foetal heart rate disorder * 1  130/428 (30.37%)  130 129/443 (29.12%)  129 132/436 (30.28%)  132
Meconium in amniotic fluid * 1  38/428 (8.88%)  38 45/443 (10.16%)  45 44/436 (10.09%)  44
uterine contractions abnormal * 1  83/428 (19.39%)  86 61/443 (13.77%)  63 81/436 (18.58%)  89
uterine hypertonus * 1  17/428 (3.97%)  17 16/443 (3.61%)  16 25/436 (5.73%)  25
Perineal laceration * 1  21/428 (4.91%)  21 28/443 (6.32%)  28 21/436 (4.82%)  21
post partum hemorrhage * 1  17/428 (3.97%)  17 16/443 (3.61%)  16 21/436 (4.82%)  21
Vascular disorders       
Hypotension * 1  18/428 (4.21%)  18 21/443 (4.74%)  21 23/436 (5.28%)  23
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (6.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Barbara L. Powers
Organization: Cytokine PharmaSciences, Inc.
Phone: 610-687-1776 ext 214
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00308711     History of Changes
Other Study ID Numbers: Miso-Obs-004
First Submitted: March 27, 2006
First Posted: March 30, 2006
Results First Submitted: July 29, 2009
Results First Posted: February 19, 2010
Last Update Posted: June 25, 2012