Analysis of ROM Plus to Detect Rupture of Membranes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Analysis of ROM Plus to Detect Rupture of Membranes

Conditions
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Rupture of Amniotic Membranes

Intervention / Treatment
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* Procedure: Sterile speculum exam
* Procedure: ROM Plus Exam
* Procedure: Chart Reveiw


Participation Criteria
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Eligibility Criteria
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Exclusion Criteria: Known placental previa Active vaginal bleeding

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| women pregnant<br>Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes. | Procedure: Sterile speculum exam<br>* Sterile vaginal speculum exam to include Nitrazine, ferning and pooling observations<br>Procedure: ROM Plus Exam<br>* Vaginal swab exam for ROM Plus Test<br>Procedure: Chart Reveiw<br>* Post delivery blinded chart review by expereienced obstetrician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ferning, 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