Preterm Birth, Preterm Labor
Conditions
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.
Interventions
DEVICEPAMG-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.
Sponsors
Mark Santillan
AmniSure International LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* women 18 to 50 years of age * being seen at the University of Iowa Women's Healthcare Clinic
Exclusion criteria
* men
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Number of participants with PAMG-1 test results that matched the results of gold standard testing |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| 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. | 42 |
| 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. | 87 |
| Total | 162 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 1 | 2 |
Baseline characteristics
| Characteristic | Pregnant Subjects | Pregnant Controls | Non Pregnant Controls | Total |
|---|---|---|---|---|
| Age, Continuous | 25.7 years | 29.2 years | 31.2 years | 29.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 41 Participants | 86 Participants | 158 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 3 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) White | 30 Participants | 34 Participants | 79 Participants | 143 Participants |
| Sex: Female, Male Female | 33 Participants | 42 Participants | 87 Participants | 162 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 42 | 0 / 87 |
| other Total, other adverse events | 0 / 33 | 0 / 42 | 0 / 87 |
| serious Total, serious adverse events | 0 / 33 | 0 / 42 | 0 / 87 |
Outcome results
Primary
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
Time frame: The assessment of the accurance PAMG-1 is completed by the end of the first study visit; one day.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregnant Subjects | Number of Participants With PAMG-1 Test Results That Matched the Results of Gold Standard Testing | 27 participants |
| Pregnant Controls | Number of Participants With PAMG-1 Test Results That Matched the Results of Gold Standard Testing | 41 participants |
| Non Pregnant Controls | Number of Participants With PAMG-1 Test Results That Matched the Results of Gold Standard Testing | 83 participants |