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

NCT ID: NCT03715530

Last Updated: 2019-10-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2011-07-31

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.

Conditions

Preterm Labor; Preterm Birth

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PAMG-1 immunoassay

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

PAMG-1 immunoassay

Intervention Type: 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

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.

Group Type: SHAM_COMPARATOR

PAMG-1 immunoassay

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• men

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AmniSure International LLC

OTHER

Sponsor Role: collaborator

Mark Santillan

OTHER

Sponsor Role: lead

Responsible Party

Mark Santillan

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Mark Santillan, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

200706757

Identifier Type: -

Identifier Source: org_study_id