Analysis of ROM Plus to Detect Rupture of Membranes | NCT01366443

Analysis of ROM Plus to Detect Rupture of Membranes | NCT01366443 | Trialant

Sponsor/Collaborators Module

Name	Class
Midwestern University	OTHER
The Reading Hospital and Medical Center	OTHER
University of Utah	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
women pregnant		Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.	Procedure: Sterile speculum exam Procedure: ROM Plus Exam Procedure: Chart Reveiw

Name	Type	Description	Arm Group Labels	Other Names
Sterile speculum exam	Procedure	Sterile vaginal speculum exam to include Nitrazine, ferning and pooling observations	women pregnant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus	Patients underwent two assessments to determine positive or negative membrane rupture status: (1) Standard clinical assessment using fluid leaking from the cervical os, or two of the following; pooling, positive nitrazine test, or ferning and (2) A new combination immunoassay ROM Plus containing a combination of monoclonal and polyclonal antibodies to Placental Protein 12 (PP12) and Alpha-fetoprotein (AFP). Then, membrane rupture status was determined by chart review for reference based on a post delivery patient chart review by an experienced physician blinded to ROM Plus results.	1 week

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
University of Utah Medical Center		Salt Lake City	Utah	894132	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	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.

ID	Title	Description
FG000	Women Pregnant	Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG000288 subjects
COMPLETED		FG000285 subjects
NOT COMPLETED		FG0003 subjects

Type	Comment	Reasons
Lost to Follow-up		FG0002 subjects
Under 18 yo		FG0001 subjects

Baseline Characteristics Module

ID	Title	Description
BG000	Women Pregnant	Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus

Patients underwent two assessments to determine positive or negative membrane rupture status: (1) Standard clinical assessment using fluid leaking from the cervical os, or two of the following; pooling, positive nitrazine test, or ferning and (2) A new combination immunoassay ROM Plus containing a combination of monoclonal and polyclonal antibodies to Placental Protein 12 (PP12) and Alpha-fetoprotein (AFP). Then, membrane rupture status was determined by chart review for reference based on a post delivery patient chart review by an experienced physician blinded to ROM Plus results.

Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes who underwent all three assessments.

Posted

Number

participants

1 week

ID	Title	Description
OG000	Pregnant Women (Clinical Assessment vs. Chart Review)

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Women Pregnant	Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.

More Info Module

Certain Agreements

Point of Contact

Title	Organization	Phone	Extension	Email
Dr. Michael Draper, MD University of Utah Medical Center, Dept. of OB/GYN	University of Utah Medical Center, Dept. of OB/GYN	801-581-7647		mike.draper@hsc.utah.edu

Title

Denominators

Categories

True Negative Membrane Rupture

Title	Measurements
	OG00095(0.97 to 1.00) OG00188

True Positive Membrane Rupture

Title	Measurements
	OG000160 OG001187

False Negative Membrane Rupture

Title	Measurements
	OG0002 OG0019

False Positive Membrane Rupture

Title	Measurements
	OG00028 OG0011

Group IDs	Group Description	Parameter Type	Parameter Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type
OG000	Sensitivity = true positives/(true positives + false negatives); It indicates how likely is the test to detect the presence of a characteristic in someone with the characteristic.	Sensitivity	0.85	2-Sided	95	0.79	0.89	The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the "Wilson" option.	No	Superiority or Other
OG000	Specificity = true negatives/(false positives + true negatives); It indicates how likely the test is to detect the absence of a characteristic in someone without the characteristic.	Specificity	0.98	2-Sided	95	0.93	0.99	The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the "Wilson" option.	No	Superiority or Other
OG000	Positive Predictive Value = true positives/(true positives + false positives); It indicates how likely it is that someone with a positive test result will actually have the characteristic.	Positive Predictive Value	0.99	2-Sided	95	0.96	1.00	The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the "Wilson" option.	No	Superiority or Other
OG000	Negative Predictive Value = true negatives/(true negatives + false negatives); It indicates how likely it is that someone with a negative test result will actually not have the characteristic.	Negative Predictive Value	0.77	2-Sided	95	0.69	0.84	The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the "Wilson" option.	No	Superiority or Other
OG001	Sensitivity = true positives/(true positives + false negatives); It indicates how likely is the test to detect the presence of a characteristic in someone with the characteristic.	Sensitivity	0.99	2-Sided	95	0.97	1.00	The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the "Wilson" option.	No	Superiority or Other
OG001	Specificity = true negatives/(false positives + true negatives); It indicates how likely the test is to detect the absence of a characteristic in someone without the characteristic.	Specificity	0.91	2-Sided	95	0.83	0.95	The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the "Wilson" option.	No	Superiority or Other
OG001	Positive Predictive Value = true positives/(true positives + false positives); It indicates how likely it is that someone with a positive test result will actually have the characteristic.	Positive Predictive Value	0.95	2-Sided	95	0.90	0.98	The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the "Wilson" option.	No	Superiority or Other
OG001	Negative Predictive Value = true negatives/(true negatives + false negatives); It indicates how likely it is that someone with a negative test result will actually not have the characteristic.	Negative Predictive Value	0.99	2-Sided	95	0.94	1.00	The calculation for the Wilson CI is computed using the cii (confidence interval immediate) command in Stata version 11.2, with the "Wilson" option.	No	Superiority or Other