Analysis of ROM Plus to Detect Rupture of Membranes

This study has been completed.
Sponsor:
Collaborators:
Midwestern University
The Reading Hospital and Medical Center
University of Utah
Information provided by (Responsible Party):
Clinical Innovations, LLC
ClinicalTrials.gov Identifier:
NCT01366443
First received: June 2, 2011
Last updated: July 30, 2012
Last verified: July 2012
Results First Received: April 26, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Rupture of Amniotic Membranes
Interventions: Procedure: Sterile speculum exam
Procedure: ROM Plus Exam
Procedure: Chart Reveiw

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients recruited from July 2010 to May 2011 at three Medical Hospitals, Departments of Obstetric and Gynecology Labor and Delivery Wards.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No particpants were excluded that matched the particpant enrollment of evaluation for suspicion of rupture of amniotic membranes by standard speculum examination for cervical leaking, pooling, ferning and nitrazine.

Reporting Groups
  Description
Women Pregnant Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.

Participant Flow:   Overall Study
    Women Pregnant  
STARTED     288  
COMPLETED     285  
NOT COMPLETED     3  
Lost to Follow-up                 2  
Under 18 yo                 1  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Women Pregnant Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.

Baseline Measures
    Women Pregnant  
Number of Participants  
[units: participants]
  288  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     287  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  27.26  ± 5.81  
Gender  
[units: participants]
 
Female     288  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     288  



  Outcome Measures

1.  Primary:   Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus   [ Time Frame: 1 week ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Dr. Michael Draper, MD University of Utah Medical Center, Dept. of OB/GYN
Organization: University of Utah Medical Center, Dept. of OB/GYN
phone: 801-581-7647
e-mail: mike.draper@hsc.utah.edu


No publications provided


Responsible Party: Clinical Innovations, LLC
ClinicalTrials.gov Identifier: NCT01366443     History of Changes
Other Study ID Numbers: ROM Plus Clinical Study
Study First Received: June 2, 2011
Results First Received: April 26, 2012
Last Updated: July 30, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration