An observational study in Rupture of Amniotic Membranes, sponsored by Clinical Innovations, LLC. Completed at 1 site in United States. Open to female participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-31.
Sponsored by Clinical Innovations, LLC · Observational
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.
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.
557 studies on the registry are indexed under Rupture; 97 are open to participants now.
This study's enrollment of 288 is above the median of 100 across 203 observational studies indexed under Rupture.
Browse Rupture studies →Clinical Innovations, LLC is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
Exclusion Criteria:
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
Sterile vaginal speculum exam to include Nitrazine, ferning and pooling observations
Vaginal swab exam for ROM Plus Test
Post delivery blinded chart review by expereienced obstetrician
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
Patients recruited from July 2010 to May 2011 at three Medical Hospitals, Departments of Obstetric and Gynecology Labor and Delivery Wards.
| Milestone | Women Pregnant |
|---|---|
| Started | 288 |
| Completed | 285 |
| Not completed | 3 |
| Withdrew: Lost to follow-up | 2 |
| Withdrew: Under 18 yo | 1 |
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.
| participants | Pregnant Women (Clinical Assessment vs. Chart Review) | Pregnant Women (ROM Plus vs. Chart Review) |
|---|---|---|
| True Negative Membrane Rupture | 95 (0.97 to 1.00) | 88 |
| True Positive Membrane Rupture | 160 | 187 |
| False Negative Membrane Rupture | 2 | 9 |
| False Positive Membrane Rupture | 28 | 1 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Women Pregnant | — | 0/288 (0%) | 0/288 (0%) |
| Age, Categorical(Participants) | Women Pregnant |
|---|---|
| <=18 years | 1 |
| Between 18 and 65 years | 287 |
| >=65 years | 0 |
| Age Continuous(years) | Women Pregnant |
|---|---|
| Mean | 27.26 ± 5.81 |
| Sex: Female, Male(Participants) | Women Pregnant |
|---|---|
| Female | 288 |
| Male | 0 |
| Region of Enrollment(participants) | Women Pregnant |
|---|---|
| United States | 288 |
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Clinical Innovations, LLC