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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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Misoprostol Vaginal Insert (MVI) 100 Misoprostol vaginal insert 100 mcg over a period of up to 24 h
Misoprostol Vaginal Insert (MVI) 50 Misoprostol vaginal insert 50 mcg over a period of up to 24 h
Cervidil 10 mg Vaginal Insert Cervidil 10 mg vaginal insert over a period of up to 24h

Participant Flow:   Overall Study
    Misoprostol Vaginal Insert (MVI) 100   Misoprostol Vaginal Insert (MVI) 50   Cervidil 10 mg Vaginal Insert
STARTED   428   444   436 
COMPLETED   426   440   431 
NOT COMPLETED   2   4   5 
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 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Misoprostol Vaginal Insert (MVI) 100 Misoprostol vaginal insert 100 mcg over a period of up to 24 h
Misoprostol Vaginal Insert (MVI) 50 Misoprostol vaginal insert 50 mcg over a period of up to 24 h
Cervidil 10 mg Vaginal Insert Cervidil 10 mg vaginal insert over a period of up to 24h
Total Total of all reporting groups

Baseline Measures
   Misoprostol Vaginal Insert (MVI) 100   Misoprostol Vaginal Insert (MVI) 50   Cervidil 10 mg Vaginal Insert   Total 
Overall Participants Analyzed 
[Units: Participants]
 428   444   436   1308 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   428   444   436   1308 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.2  (5.9)   26.9  (6.2)   26.0  (5.7)   26.4  (5.9) 
Gender 
[Units: Participants]
       
Female   428   444   436   1308 
Male   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
United States   413   427   419   1259 
Canada   15   17   17   49 
Parity [1] 
[Units: Participants]
       
Nulliparous   267   275   270   812 
Parous   161   169   166   496 
[1] 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] 
[Units: Units on a scale of 0 (low) to 12 (most)]
Mean (Standard Deviation)
 2.69  (1.1)   2.74  (1.1)   2.73  (1.1)   2.72  (1.1) 
[1] 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.


  Outcome Measures

1.  Primary:   Minutes From Drug Insertion to Vaginal Delivery   [ Time Frame: 2880 minutes ]

2.  Primary:   Percentage of Participants With a Cesarean Section Delivery   [ Time Frame: 2880 minutes ]

3.  Secondary:   Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events   [ Time Frame: 96 hours ]

4.  Secondary:   Percentage of Participants With Pre-Delivery Oxytocin Use   [ Time Frame: 2880 minutes ]

5.  Secondary:   Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert   [ Time Frame: 12 hours ]

6.  Secondary:   Minutes to Onset of Active Labor   [ Time Frame: 2880 minutes ]

7.  Secondary:   Minutes to Rupture of Membranes (ROM)   [ Time Frame: 2880 minutes ]

8.  Secondary:   Duration of Stay in Minutes in Labor and Delivery Suite   [ Time Frame: 5760 minuts ]

9.  Secondary:   Days in Hospital for Mother and Neonate   [ Time Frame: 10 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: bpowers@cytokinepharmasciences.com


Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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