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

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ClinicalTrials.gov Identifier: NCT03715530
Recruitment Status : Terminated (Data collection has halted due to no further assays provided by AmniSURE)
First Posted : October 23, 2018
Results First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Collaborator:
AmniSure International LLC
Information provided by (Responsible Party):
Mark Santillan, University of Iowa

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Preterm Labor Preterm Birth Device: PAMG-1 immunoassay Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : September 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Pregnant subjects
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
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.

Active Comparator: Pregnant controls
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
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.

Sham Comparator: Non pregnant controls
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
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.




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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women 18 to 50 years of age
  • being seen at the University of Iowa Women's Healthcare Clinic

Exclusion Criteria:

  • men

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715530


Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Mark Santillan
AmniSure International LLC
Investigators
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Principal Investigator: Mark Santillan, MD, PhD University of Iowa

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Responsible Party: Mark Santillan, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT03715530     History of Changes
Other Study ID Numbers: 200706757
First Posted: October 23, 2018    Key Record Dates
Results First Posted: October 3, 2019
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Fetal Membranes, Premature Rupture
Rupture
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries