Preterm LaborPAMG-1NCT03715530
Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women
A study testing PAMG-1 immunoassay in people with Preterm Labor and Preterm Birth, run by Mark Santillan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Preterm Labor, Preterm Birth
- What is being tested?
- PAMG-1 immunoassay
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jul 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women 18 to 50 years of age
- being seen at the University of Iowa Women's Healthcare Clinic
Who cannot join
- men
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Preterm Labor, Preterm Birth
- Being tested
- PAMG-1 immunoassay
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAMG-1 immunoassayDevice
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 group | Role | What they receive |
|---|---|---|
| Pregnant subjects | Experimental | 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. Receives: Device: PAMG-1 immunoassay |
| Pregnant controls | Active comparator | 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. Receives: Device: PAMG-1 immunoassay |
| Non pregnant controls | Sham comparator | 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. Receives: Device: PAMG-1 immunoassay |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The assessment of the accurance PAMG-1 is completed by the end of the first study visit; one day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study startSep 2007
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Data collection has halted due to no further assays provided by AmniSURE
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mark Santillan
- Sponsor type
- University, hospital or other
- Collaborators
- AmniSure International LLC
- Responsible party
- Sponsor-investigator, Mark Santillan, University of Iowa
- Investigators
- Mark Santillan, MD, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715530
- Sponsor's protocol ID
- 200706757
- Acronym
- PAMG-1
- Status last verified
- Oct 2019
- First submitted
- 16 Oct 2018
- Last updated
- 3 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03715530
- Acronym / sponsor ID
- PAMG-1 / 200706757
- Conditions
- Preterm Labor, Preterm Birth
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data collection has halted due to no further assays provided by AmniSURE
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Mark SantillanUniversity, hospital or other
- Collaborators
- AmniSure International LLC
- Study start
- Sep 2007 (actual)
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Posted 3 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pregnant subjects | Experimental | Device: PAMG-1 immunoassayThese 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. |
| Pregnant controls | Active comparator | Device: PAMG-1 immunoassayThese 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. |
| Non pregnant controls | Sham comparator | Device: PAMG-1 immunoassayThese 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- women 18 to 50 years of age
- being seen at the University of Iowa Women's Healthcare Clinic
Key exclusion criteria (1 listed)
- men
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAMG-1 immunoassayThe 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. | Device | Non pregnant controls, Pregnant controls, Pregnant subjects |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Santillan, MD, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAMG-1 immunoassay in people with Preterm Labor and Preterm Birth, run by Mark Santillan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.