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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

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Preterm Labor
Preterm Birth
Intervention Device: PAMG-1 immunoassay
Enrollment 162
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pregnant Subjects Pregnant Controls Non Pregnant Controls
Hide Arm/Group Description

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.

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.

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.

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.

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.

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.

Period Title: Overall Study
Started 33 42 87
Completed 30 41 85
Not Completed 3 1 2
Reason Not Completed
Lost to Follow-up             3             1             2
Arm/Group Title Pregnant Subjects Pregnant Controls Non Pregnant Controls Total
Hide Arm/Group Description

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.

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.

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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 33 42 87 162
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 33 participants 42 participants 87 participants 162 participants
25.7
(18 to 37)
29.2
(19 to 42)
31.2
(18 to 49)
29.6
(18 to 49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 42 participants 87 participants 162 participants
Female
33
 100.0%
42
 100.0%
87
 100.0%
162
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 42 participants 87 participants 162 participants
Hispanic or Latino
2
   6.1%
1
   2.4%
1
   1.1%
4
   2.5%
Not Hispanic or Latino
31
  93.9%
41
  97.6%
86
  98.9%
158
  97.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 42 participants 87 participants 162 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   2.4%
3
   3.4%
4
   2.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
4
   9.5%
5
   5.7%
9
   5.6%
White
30
  90.9%
34
  81.0%
79
  90.8%
143
  88.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   9.1%
3
   7.1%
0
   0.0%
6
   3.7%
1.Primary Outcome
Title Number of Participants With PAMG-1 Test Results That Matched the Results of Gold Standard Testing
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pregnant Subjects Pregnant Controls Non Pregnant Controls
Hide Arm/Group Description:

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.

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.

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.

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.

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.

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.

Overall Number of Participants Analyzed 30 41 85
Measure Type: Number
Unit of Measure: participants
27 41 83
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pregnant Subjects Pregnant Controls Non Pregnant Controls
Hide Arm/Group Description

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.

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.

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.

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.

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.

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.

All-Cause Mortality
Pregnant Subjects Pregnant Controls Non Pregnant Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/42 (0.00%)   0/87 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Pregnant Subjects Pregnant Controls Non Pregnant Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/42 (0.00%)   0/87 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pregnant Subjects Pregnant Controls Non Pregnant Controls
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)   0/42 (0.00%)   0/87 (0.00%) 

Data collection has halted due to no further assays provided by AmniSURE.

No statistical analysis was completed at this time.

Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Mark Santillan
Organization: University of Iowa
Phone: 319-356-3180
EMail: mark-santillan@uiowa.edu
Layout table for additonal information
Responsible Party: Mark Santillan, University of Iowa
ClinicalTrials.gov Identifier: NCT03715530     History of Changes
Other Study ID Numbers: 200706757
First Submitted: October 16, 2018
First Posted: October 23, 2018
Results First Submitted: September 12, 2019
Results First Posted: October 3, 2019
Last Update Posted: October 3, 2019