Premature Rupture of MembranesNCT02495441
Rapid Immunoassay Tests for the Detection of Ruptured Membranes
An observational study of Premature Rupture of Membranes, run by De Soysa Hospital for Women at 1 site in Sri Lanka.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Premature Rupture of Membranes
- What is being tested?
- Use of Rapid Immunoassay Tests for the Detection of PROM
- How many people
- 100 participants
- Where
- 1 siteSri Lanka
- Study dates
- Aug 2015to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Any woman who presents with alleged leakage of amniotic fluid is eligible for recruitment
Who cannot join
- Known placental previa
- Active vaginal bleeding
Trial locations and contacts
1 site in 1 country.
Sri Lanka1 site, 1 recruiting
- Recruiting
De Soyza Hospital for Women
Colombo, Western Province
Hemantha Senanayake, MS, FRCOG, 94714762176, senanayakeh@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Premature Rupture of Membranes
- Being tested
- Use of Rapid Immunoassay Tests for the Detection of PROM
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Rapid Immunoassay Tests for the Detection of PROMOther
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®.
| Study group | Role | What they receive |
|---|---|---|
| Dribbling group | Any woman who presents with alleged leakage of amniotic fluid. They will under go rapid Immunoassay Tests for the Detection of PROM Receives: Other: Use of Rapid Immunoassay Tests for the Detection of PROM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that become positive for pre labor rupture of membranes by the immunological test kits.
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.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2015 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Rupture of MembranesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- De Soysa Hospital for Women
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Innovations, LLC
- Responsible party
- Principal investigator, Hemantha M. Senanayake, De Soysa Hospital for Women
- Investigators
- Hemantha Senanayake, MS, FRCOG, Principal investigator, Department of Obstetrics & Gynaecology Faculty of Medicine University of Colombo, Sri Lanka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495441
- Sponsor's protocol ID
- PROM
- Status last verified
- Jul 2015
- First submitted
- 1 Jul 2015
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Rapid Immunoassay Tests for the Detection of Ruptured Membranes
- ClinicalTrials.gov ID
- NCT02495441
- Acronym / sponsor ID
- PROM
- Conditions
- Premature Rupture of Membranes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- De Soysa Hospital for WomenUniversity, hospital or other
- Collaborators
- Clinical Innovations, LLC
- Study start
- Aug 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dribbling group | – | Other: Use of Rapid Immunoassay Tests for the Detection of PROMAny woman who presents with alleged leakage of amniotic fluid. They will under go rapid Immunoassay Tests for the Detection of PROM |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Any woman who presents with alleged leakage of amniotic fluid is eligible for recruitment
Key exclusion criteria (2 listed)
- Known placental previa
- Active vaginal bleeding
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 |
|---|---|---|
| Use of Rapid Immunoassay Tests for the Detection of PROMAfter 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®. | Other | Dribbling group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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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.
Hemantha Senanayake, MS, FRCOG principal investigator
Department of Obstetrics & Gynaecology Faculty of Medicine University of Colombo, Sri Lanka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Rupture of Membranes, run by De Soysa Hospital for Women at 1 site in Sri Lanka.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Aug 2015. 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 Sri Lanka. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hemantha Senanayake, MS, FRCOG (+94714762176, senanayakeh@gmail.com,), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that become positive for pre labor rupture of membranes by the immunological test kits. (time frame: up to 1 year). 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 7 Aug 2015.