Analysis of ROM Plus to Detect Rupture of Membranes

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. Identifier: NCT01366443
Recruitment Status : Completed
First Posted : June 6, 2011
Results First Posted : July 31, 2012
Last Update Posted : July 31, 2012
Midwestern University
The Reading Hospital and Medical Center
University of Utah
Information provided by (Responsible Party):
Clinical Innovations, LLC

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

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
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 
Lost to Follow-up                2 
Under 18 yo                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
Women Pregnant Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.

Baseline Measures
   Women Pregnant 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   1 
Between 18 and 65 years   287 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 27.26  (5.81) 
[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

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

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

Lee SI, Park JS, Norwitz ER et al. Measurement of placental alpha-microglobulin-1 in cervicovaginal discharge to diagnose rupture of membranes, Obstet Gyencol 2007;109:634-40 Cousins, LM, Smok, P. Lovett, SM, Poeltler, DM. AmniSure Placental Alpha Microglobulin-1 Rapid Immunoassay versus Standard Diagnostic Methods for Detection of Rupture of Membranes. American J. of Perinatology. 2005;Vol.20:1-4. Caughey, AB., Robinson, JN., Norwitz, ER. Contemporary Diagnosis and Management of Preterm Premature Rupture of Membranes. Rev. Obstet. Gynecol. 2008;1(1):11-22.

Responsible Party: Clinical Innovations, LLC Identifier: NCT01366443     History of Changes
Other Study ID Numbers: ROM Plus Clinical Study
First Submitted: June 2, 2011
First Posted: June 6, 2011
Results First Submitted: April 26, 2012
Results First Posted: July 31, 2012
Last Update Posted: July 31, 2012