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

History of Changes

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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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 ]

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Serious Adverse Events

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Other Adverse Events

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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.

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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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

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