Rapid Immunoassay Tests for the Detection of Ruptured Membranes

August 6, 2015 updated by: Hemantha M. Senanayake, De Soysa Hospital for Women

A Comparison of Rapid Immunoassay Tests for the Detection of Ruptured Membranes

The aim of the study is to demonstrate substantial equivalence of IGFBP-1/AFP tests with the "predicate device" Amnisure® in detecting pre labor rupture of membranes. 4 test kits are compared against a common referent standard (gold standard), which is clinical assessment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Premature rupture of membranes (PROM) is defined as spontaneous rupture of membranes (ROM) before the onset of uterine contractions. Its diagnosis is often obvious with the woman presenting with leakage of amniotic fluid, but it could also turn out to be a difficult diagnostic dilemma.

The diagnosis of fetal membrane rupture is conventionally made using a clinical assessment. First, by speculum examination, the clinician looks for amniotic fluid leaking from the cervical os. If clear fluid is visualized leaking from the cervical os, the diagnosis is positive for fetal membrane rupture. More commonly, leaking is absent, and a more extensive workup is required, which includes nitrazine/pH testing, visual inspection of pooling of fluid in the posterior fornix, and a microscopic evaluation of the collected specimen (ferning). Although this approach is considered the standard of care, it is fraught with inaccuracies, requires an intrusive examination and may not provide a rapid diagnosis.

Rapid, point of care, qualitative immunochromatographic tests (ie., Amnisure®, ActimProm®, Amnioquick® Complete and ROM Plus®) that detect proteins found in amniotic fluid at high concentrations, have been used to diagnose the rupture of membranes (ROM) for several years. In many hospitals, Amnisure® has replaced the sterile speculum exam as the standard of care for diagnosing ROM. It identifies Placental Alpha Microglobulin-1 (PAMG-1), a 34 kd fetal glycoprotein, in cervicovaginal secretions.

ROM Plus® ActimProm®and Amnioquick® Complete+ are newer additions into the market for testing for PROM. Both these tests use a monoclonal/polyclonal antibody approach to detect two different proteins found in amniotic fluid at high concentrations. They detect Placental Protein-12 (also known as Insulin-like Growth Factor Binding Protein-1 - IGFBP-1) as well as Alpha Fetoprotein (AFP).

The aim of the study is to demonstrate substantial equivalence of IGFBP-1/AFP tests with the "predicate device" Amnisure®. Stated in statistical terms, the aim is to demonstrated that IGFBP-1/AFP tests are non-inferior to Amnisure® in terms of sensitivity and specificity when both are compared in a paired-sample fashion to a common referent standard (gold standard), which is clinical assessment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Sri Lanka
    • Western
      • Colombo, Western, Sri Lanka
        • Recruiting
        • De Soyza Hospital for Women
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study population includes the pregnant mothers presenting to the De Soysa Hospital for Women, Colombo with alleged leakage of amniotic fluid. This is an urban population with multiple ethical back grounds.

Description

Inclusion Criteria:

  • Any woman who presents with alleged leakage of amniotic fluid is eligible for recruitment

Exclusion Criteria:

  • Known placental previa
  • Active vaginal bleeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Dribbling group
Any woman who presents with alleged leakage of amniotic fluid. They will under go rapid Immunoassay Tests for the Detection of PROM
Other: Use of Rapid Immunoassay Tests for the Detection of PROM

After informed consent , both the ROM Plus®, ActimProm Amnioquick® Complete and AmniSure® bedside tests (without the use of a speculum) will be performed.

The patient will then undergo the standard clinical assessment, which includes a sterile speculum exam (SSE). If either 1) amniotic fluid is seen leaking from the cervical os, or 2) if at least two of the following three clinical signs are present: visual pooling of fluid in the posterior fornix, positive nitrazine test, and microscopic evidence of ferning, then the patient will be considered positive for ROM.

Women who cannot be confirmed clinically by the SSE will undergo an ultrasound evaluation to determine the amniotic fluid index. The patient will be treated according to the results of the SSE and ultrasound, not the results of IGFBP-1/AFP tests and Amnisure®.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants that become positive for pre labor rupture of membranes by the immunological test kits.
Time Frame: up to 1 year
This will be assessed by the performing 4 immunological tests and clinical assessment. These test kits includes ROM Plus, ActimProm®, Amnioquick® and Amnisure. Outcomes of the immune tests will be compared against a gold stranded clinical assessment.
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
De Soysa Hospital for Women

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Clinical Innovations, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hemantha Senanayake, MS, FRCOG, Department of Obstetrics & Gynaecology Faculty of Medicine University of Colombo, Sri Lanka

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PROM

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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