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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

Tracking Information
First Submitted Date  ICMJE October 16, 2018
First Posted Date  ICMJE October 23, 2018
Results First Submitted Date  ICMJE September 12, 2019
Results First Posted Date  ICMJE October 3, 2019
Last Update Posted Date October 3, 2019
Actual Study Start Date  ICMJE September 2007
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2018)
Accuracy of the PAMG-1 immunoassay [ Time Frame: The assessment of the accurance PAMG-1 is completed by the end of the first study visit; one day. ]
Comparison of accuracy of the PAMG-1 to standard diagnostic methods for rupture of membranes including clinical history, the sterile speculum exam and the amniodye test as the gold standard.
Change History Complete list of historical versions of study NCT03715530 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Preterm Labor
  • Preterm Birth
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: PAMG-1 immunoassay
  • 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.
    Intervention: Device: PAMG-1 immunoassay
  • 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.
    Intervention: Device: PAMG-1 immunoassay
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 19, 2018)
162
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • men
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03715530
Other Study ID Numbers  ICMJE 200706757
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mark Santillan, University of Iowa
Study Sponsor  ICMJE Mark Santillan
Collaborators  ICMJE AmniSure International LLC
Investigators  ICMJE
Principal Investigator: Mark Santillan, MD, PhD University of Iowa
PRS Account University of Iowa
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP