Use of Placental Alpha Microglobulin-1(PAMG-1) to Diagnose Premature Rupture of Membranes in Pregnant Women

• Sponsor: Mark Santillan (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03715530
• Collaborator: AmniSure International LLC (Other)
• Enrollment: 162
• Location: 1
• Arms: 3
• Actual Duration (Months): 46
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Labor; Preterm Birth	Device: PAMG-1 immunoassay	N/A

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

• Study Type: Interventional
• Actual Enrollment: 162 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Jul 1, 2011
• Actual Study Completion Date: Jul 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.
Active Comparator: 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.	Device: 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.
Sham Comparator: 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.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

• Mark Santillan
• AmniSure International LLC

Investigators

• Principal Investigator: Mark Santillan, MD, PhD, University of Iowa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mark Santillan, Principal Investigator, University of Iowa
• ClinicalTrials.gov Identifier: NCT03715530
• Other Study ID Numbers: 200706757
• First Posted: Oct 23, 2018
• Last Update Posted: Oct 3, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Premature Birth; Obstetric Labor, Premature; Fetal Membranes, Premature Rupture; Rupture

Study Results

Participant Flow

Arm/Group Title	Pregnant Subjects	Pregnant Controls	Non Pregnant Controls
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

Baseline Characteristics

Arm/Group Title	Pregnant Subjects	Pregnant Controls	Non Pregnant Controls	Total
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 Participants	33	42	87	162
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	25.7	29.2	31.2	29.6
Sex: Female, Male (Count of Participants)
Female	33 100%	42 100%	87 100%	162 100%
Male	0 0%	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of 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%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	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%
Black or African American	0 0%	4 9.5%	5 5.7%	9 5.6%
White	30 90.9%	34 81%	79 90.8%	143 88.3%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	3 9.1%	3 7.1%	0 0%	6 3.7%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With PAMG-1 Test Results That Matched the Results of Gold Standard Testing
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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pregnant Subjects	Pregnant Controls	Non Pregnant Controls
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.
Measure Participants	30	41	85
Number [participants]	27 81.8%	41 97.6%	83 95.4%

Adverse Events

Arm/Group Title	Pregnant Subjects		Pregnant Controls		Non Pregnant Controls
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/42 (0%)		0/87 (0%)
Serious Adverse Events
	Pregnant Subjects		Pregnant Controls		Non Pregnant Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/42 (0%)		0/87 (0%)
Other (Not Including Serious) Adverse Events
	Pregnant Subjects		Pregnant Controls		Non Pregnant Controls
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/42 (0%)		0/87 (0%)

Limitations/Caveats

Data collection has halted due to no further assays provided by AmniSURE. No statistical analysis was completed at this time.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.