Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women
| Status: | Terminated |
|---|---|
| Conditions: | Women's Studies, Women's Studies, Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 10/25/2018 |
| Start Date: | September 2007 |
| End Date: | July 2011 |
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
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.
women has ruptured membranes in comparison to standardly used testing methods.
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.
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.
Inclusion Criteria:
- women 18 to 50 years of age
- being seen at the University of Iowa Women's Healthcare Clinic
Exclusion Criteria:
- men
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