Trial Outcomes & Findings for Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women (NCT NCT03715530)
NCT ID: NCT03715530
Last Updated: 2019-10-03
Results Overview
Number of participants with PAMG-1 test results that matched the results of gold standard testing
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
162 participants
Primary outcome timeframe
The assessment of the accurance PAMG-1 is completed by the end of the first study visit; one day.
Results posted on
2019-10-03
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
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.
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 Study
STARTED
|
33
|
42
|
87
|
|
Overall Study
COMPLETED
|
30
|
41
|
85
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
2
|
Reasons for withdrawal
| Measure |
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.
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.
|
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.
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.
|
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.
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 Study
Lost to Follow-up
|
3
|
1
|
2
|
Baseline Characteristics
Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women
Baseline characteristics by cohort
| Measure |
Pregnant Subjects
n=33 Participants
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.
|
Pregnant Controls
n=42 Participants
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.
|
Non Pregnant Controls
n=87 Participants
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
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25.7 years
n=5 Participants
|
29.2 years
n=7 Participants
|
31.2 years
n=5 Participants
|
29.6 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
162 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
158 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Pregnant Subjects
n=30 Participants
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.
|
Pregnant Controls
n=41 Participants
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.
|
Non Pregnant Controls
n=85 Participants
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.
|
|---|---|---|---|
|
Number of Participants With PAMG-1 Test Results That Matched the Results of Gold Standard Testing
|
27 participants
|
41 participants
|
83 participants
|
Adverse Events
Pregnant Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pregnant Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non Pregnant Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place