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

NCT03715530 | Terminated Results FDA Device

• 1 other identifier: 200706757
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Labor; Preterm Birth

Outcome Measures

Primary Outcomes (1)

• 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

  The assessment of the accurance PAMG-1 is completed by the end of the first study visit; one day.

Study Arms (3)

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.

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.

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.

Device: PAMG-1 immunoassay

Interventions

PAMG-1 immunoassay DEVICE

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; Pregnant controls; Pregnant subjects

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• women 18 to 50 years of age
• being seen at the University of Iowa Women's Healthcare Clinic

You may not qualify if:

• men

Sponsors & Collaborators

• Mark Santillan: lead
• AmniSure International LLC: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Obstetric Labor, Premature; Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Limitations and Caveats

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

Results Point of Contact

• Title: Dr. Mark Santillan
• Organization: University of Iowa

mark-santillan@uiowa.edu

319-356-3180

Study Officials

• Mark Santillan, MD, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 23, 2018
• Study Start: September 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 3, 2019
• Results First Posted: October 3, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)