Rupture of Amniotic Membranes
Conditions
Keywords
ROM PLUS, conventional clinical tests of rupture of membranes (ROM), speculum exam, visualization of leakage, pooling of amniotic fluid in the posterior fornix, nitrazine testing, ferning
Brief summary
Specific objectives include confirmation: i) that the ROM PLUS consistently and accurately diagnoses rupture of membranes (ROM), ii) that the technique can be understood and applied in clinical practice, and iii) that the ROM PLUS is easier to use than the conventional method.
Detailed description
This study is designed to assess the sensitivity and specificity of ROM PLUS- a rapid, point of care, qualitative immunochromatographic test for the detection (in vitro) of amniotic fluid in cervico-vaginal secretions of women with suspected rupture of membranes (ROM) during pregnancy. The ROM PLUS detects a specific Combo protein present in amniotic fluid of pregnant women in all trimesters of pregnancy. This specific protein combo is unique and found only in amniotic fluid, therefore can be used as a specific marker for the diagnosis of ROM. This biomarker is an isoform of a similar biomarkers called Amni-Sure and ActimProm and was recently approved by the FDA for clinical use. Like these protein markers ( AmniSure or ActimProm) which have been used to diagnose PROM, this particular protein isoform tested for ROM PLUS is in low concentration in other body fluids such as maternal blood, cord blood, urine and semen.
Interventions
PROCEDURESterile speculum exam
Sterile vaginal speculum exam to include Nitrazine, ferning and pooling observations
PROCEDUREROM Plus Exam
Vaginal swab exam for ROM Plus Test
PROCEDUREChart Reveiw
Post delivery blinded chart review by expereienced obstetrician
Sponsors
Midwestern University
The Reading Hospital and Medical Center
University of Utah
Clinical Innovations, LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Exclusion criteria
* Known placental previa * Active vaginal bleeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus | 1 week | 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. |
Countries
United States
Participant flow
Recruitment details
Patients recruited from July 2010 to May 2011 at three Medical Hospitals, Departments of Obstetric and Gynecology Labor and Delivery Wards.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Women Pregnant Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes. | 288 |
| Total | 288 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Under 18 yo | 1 |
Baseline characteristics
| Characteristic | Women Pregnant |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 287 Participants |
| Age Continuous | 27.26 years STANDARD_DEVIATION 5.81 |
| Region of Enrollment United States | 288 participants |
| Sex: Female, Male Female | 288 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 288 |
| serious Total, serious adverse events | 0 / 288 |
Outcome results
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.
Time frame: 1 week
Population: Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes who underwent all three assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pregnant Women (Clinical Assessment vs. Chart Review) | Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus | True Negative Membrane Rupture | 95 participants |
| Pregnant Women (Clinical Assessment vs. Chart Review) | Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus | False Negative Membrane Rupture | 2 participants |
| Pregnant Women (Clinical Assessment vs. Chart Review) | Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus | True Positive Membrane Rupture | 160 participants |
| Pregnant Women (Clinical Assessment vs. Chart Review) | Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus | False Positive Membrane Rupture | 28 participants |
| Pregnant Women (ROM Plus vs. Chart Review) | Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus | True Positive Membrane Rupture | 187 participants |
| Pregnant Women (ROM Plus vs. Chart Review) | Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus | True Negative Membrane Rupture | 88 participants |
| Pregnant Women (ROM Plus vs. Chart Review) | Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus | False Positive Membrane Rupture | 1 participants |
| Pregnant Women (ROM Plus vs. Chart Review) | Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus | False Negative Membrane Rupture | 9 participants |
Comparison: 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.95% CI: [0.79, 0.89]
Comparison: 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.95% CI: [0.93, 0.99]
Comparison: 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.95% CI: [0.96, 1]
Comparison: 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.95% CI: [0.69, 0.84]
Comparison: 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.95% CI: [0.97, 1]
Comparison: 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.95% CI: [0.83, 0.95]
Comparison: 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.95% CI: [0.9, 0.98]
Comparison: 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.95% CI: [0.94, 1]