Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women

Study Overview
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Brief Summary
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The study is to evaluate the accuracy of a test device called PAMG-1 to see if a pregnant women has ruptured membranes in comparison to standardly used testing methods.

Detailed Description
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The study is to evaluate the accuracy of the PAMG-1 immunoassay in comparison to standard diagnostic methods for premature preterm rupture of membranes including the sterile speculum exam and the amniodye test as the gold standard. The procedure includes the insertion of a swab into the subject's vaginal vault without a speculum for one minute. Once the swab is obtained, the treating physician will place the swab in a solvent vial for one minute. A developing strip is then placed in a vial and allowed to develop for five minutes. The results are read from the developing strip. Processing of this swab will be performed without further involvement of the study participant. The insertion of the swab is a one time procedure and is the only addition to any standard of care that would applied to the patient during their clinical evaluation at that time. Given the study group and both pregnant and non-pregnant controls, standard of care procedures will include a wide variety of obstetrical and/or gynecological (OB/Gyn) procedures including but not limited to a vaginal exams, sterile speculum exams (including pap smears), biopsies, and amniocentesis. The swab for the PAMG-1 immunoassay will be performed after other evaluations are performed. Medical records of the subject and (if applicable) her newborn infant will be reviewed for data pertaining to the study, including, but not limited to, maternal and fetal outcomes at the time of enrollment and after delivery and history of the present illness requiring an OB/Gyn evaluation. The study participants will not be asked to do anything in addition to what is expected for the swab and their clinical visit. The PAMG-1 immunoassay will be obtained during the subjects regularly scheduled clinic appointment or hospital visit. No follow appointments will be needed.

Official Title
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A Comparison of the Measurement of Placental Alpha-microglobulin-1 in Cervicovaginal Discharge, Sterile Speculum Exam, and Amniodye Testing for the Diagnosis of Preterm Premature Rupture of Membranes

Conditions
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Preterm Labor, Preterm Birth

Intervention / Treatment
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* Device: PAMG-1 immunoassay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: women 18 to 50 years of age being seen at the University of Iowa Women's Healthcare Clinic Exclusion Criteria: men

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregnant subjects<br>These are pregnant women that are admitted to Labor &Delivery (L&D) or an outpatient in the Women's Health Clinic that are being evaluated for rupture of membranes. | Device: PAMG-1 immunoassay<br>* The procedure includes the insertion of a PAMG-1 swab into the subject's vaginal vault without a speculum for one minute. Once the swab is obtained, the treating physician will place the swab in a solvent vial for one minute. A developing strip is then placed in a vial and allowed to develop for five minutes. The results are read from the developing strip.<br>|
| Active Comparator: Pregnant controls<br>These women will be found primarily in the Women's Health Clinic, when being seen for their routine antepartum appointments. Most of them will be recruited at about 36 weeks, since they will be having a pelvic exam at this time, as part of their routine antepartum care. | Device: PAMG-1 immunoassay<br>* The procedure includes the insertion of a PAMG-1 swab into the subject's vaginal vault without a speculum for one minute. Once the swab is obtained, the treating physician will place the swab in a solvent vial for one minute. A developing strip is then placed in a vial and allowed to develop for five minutes. The results are read from the developing strip.<br>|
| Sham Comparator: Non pregnant controls<br>These women will be found in the Women's Health Clinic, when being seen for gynecology appointments. Nursing staff and the dashboard will help to identify those patients who will be having a pelvic exam. | Device: PAMG-1 immunoassay<br>* The procedure includes the insertion of a PAMG-1 swab into the subject's vaginal vault without a speculum for one minute. Once the swab is obtained, the treating physician will place the swab in a solvent vial for one minute. A developing strip is then placed in a vial and allowed to develop for five minutes. The results are read from the developing strip.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With PAMG-1 Test Results That Matched the Results of Gold Standard Testing | Number of participants with PAMG-1 test results that matched the results of gold standard testing | The assessment of the accurance PAMG-1 is completed by the end of the first study visit; one day. |