Rupture of Amniotic MembranesNCT01366443
Analysis of ROM Plus to Detect Rupture of Membranes
An observational study of Rupture of Amniotic Membranes, run by Clinical Innovations, LLC at 1 site in United States.
Trial summary
Specific objectives include confirmation: i) that the ROM PLUS consistently and accurately diagnoses rupture of membranes (ROM), ii) that the technique can be understood and applied in clinical practice, and iii) that the ROM PLUS is easier to use than the conventional method. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rupture of Amniotic Membranes
- What is being tested?
- Sterile speculum exam, ROM Plus Exam and Chart Reveiw
- Type of treatment
- Surgery or procedure
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Apr 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
Who may be able to join
None listed.
Who cannot join
- Known placental previa
- Active vaginal bleeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Medical Center
Salt Lake City, Utah, 894132
About this study
Specific objectives include confirmation: i) that the ROM PLUS consistently and accurately diagnoses rupture of membranes (ROM), ii) that the technique can be understood and applied in clinical practice, and iii) that the ROM PLUS is easier to use than the conventional method.
Read the detailed description
This study is designed to assess the sensitivity and specificity of ROM PLUS- a rapid, point of care, qualitative immunochromatographic test for the detection (in vitro) of amniotic fluid in cervico-vaginal secretions of women with suspected rupture of membranes (ROM) during pregnancy. The ROM PLUS detects a specific Combo protein present in amniotic fluid of pregnant women in all trimesters of pregnancy. This specific protein combo is unique and found only in amniotic fluid, therefore can be used as a specific marker for the diagnosis of ROM. This biomarker is an isoform of a similar biomarkers called Amni-Sure and ActimProm and was recently approved by the FDA for clinical use. Like these protein markers ( AmniSure or ActimProm) which have been used to diagnose PROM, this particular protein isoform tested for ROM PLUS is in low concentration in other body fluids such as maternal blood, cord blood, urine and semen.
- Conditions
- Rupture of Amniotic Membranes
- Being tested
- Sterile speculum exam, ROM Plus Exam, Chart Reveiw
- Keywords
- ROM PLUS, conventional clinical tests of rupture of membranes (ROM), speculum exam, visualization of leakage, pooling of amniotic fluid in the posterior fornix, nitrazine testing, ferning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sterile speculum examProcedure or surgery
Sterile vaginal speculum exam to include Nitrazine, ferning and pooling observations
ROM Plus ExamProcedure or surgery
Vaginal swab exam for ROM Plus Test
Chart ReveiwProcedure or surgery
Post delivery blinded chart review by expereienced obstetrician
| Study group | Role | What they receive |
|---|---|---|
| women pregnant | Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes. Receives: Procedure: Sterile speculum exam; Procedure: ROM Plus Exam; Procedure: Chart Reveiw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus
Patients underwent two assessments to determine positive or negative membrane rupture status: (1) Standard clinical assessment using fluid leaking from the cervical os, or two of the following; pooling, positive nitrazine test, or ferning and (2) A new combination immunoassay ROM Plus containing a combination of monoclonal and polyclonal antibodies to Placental Protein 12 (PP12) and Alpha-fetoprotein (AFP). Then, membrane rupture status was determined by chart review for reference based on a post delivery patient chart review by an experienced physician blinded to ROM Plus results.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2011 (estimated)
- Study startSep 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rupture of Amniotic 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
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Innovations, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Midwestern University, The Reading Hospital and Medical Center, University of Utah
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01366443
- Sponsor's protocol ID
- ROM Plus Clinical Study
- Status last verified
- Jul 2012
- First submitted
- 2 Jun 2011
- Last updated
- 31 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lee SI, Park JS, Norwitz ER et al. Measurement of placental alpha-microglobulin-1 in cervicovaginal discharge to diagnose rupture of membranes, Obstet Gyencol 2007;109:634-40 Cousins, LM, Smok, P. Lovett, SM, Poeltler, DM. AmniSure Placental Alpha Microglobulin-1 Rapid Immunoassay versus Standard Diagnostic Methods for Detection of Rupture of Membranes. American J. of Perinatology. 2005;Vol.20:1-4. Caughey, AB., Robinson, JN., Norwitz, ER. Contemporary Diagnosis and Management of Preterm Premature Rupture of Membranes. Rev. Obstet. Gynecol. 2008;1(1):11-22.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of ROM Plus to Detect Rupture of Membranes
- ClinicalTrials.gov ID
- NCT01366443
- Acronym / sponsor ID
- ROM Plus Clinical Study
- Conditions
- Rupture of Amniotic Membranes
- Keywords
- ROM PLUS, conventional clinical tests of rupture of membranes (ROM), speculum exam, visualization of leakage, pooling of amniotic fluid in the posterior fornix, nitrazine testing, ferning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Clinical Innovations, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Midwestern University, The Reading Hospital and Medical Center, University of Utah
- Study start
- Sep 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 6 Jun 2011 (estimated)
- Results
- Posted 31 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Specific objectives include confirmation: i) that the ROM PLUS consistently and accurately diagnoses rupture of membranes (ROM), ii) that the technique can be understood and applied in clinical practice, and iii) that the ROM PLUS is easier to use than the conventional method.
Detailed description
This study is designed to assess the sensitivity and specificity of ROM PLUS- a rapid, point of care, qualitative immunochromatographic test for the detection (in vitro) of amniotic fluid in cervico-vaginal secretions of women with suspected rupture of membranes (ROM) during pregnancy. The ROM PLUS detects a specific Combo protein present in amniotic fluid of pregnant women in all trimesters of pregnancy. This specific protein combo is unique and found only in amniotic fluid, therefore can be used as a specific marker for the diagnosis of ROM. This biomarker is an isoform of a similar biomarkers called Amni-Sure and ActimProm and was recently approved by the FDA for clinical use. Like these protein markers ( AmniSure or ActimProm) which have been used to diagnose PROM, this particular protein isoform tested for ROM PLUS is in low concentration in other body fluids such as maternal blood, cord blood, urine and semen.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women pregnant | – | Procedure: Sterile speculum exam, Procedure: ROM Plus Exam, Procedure: Chart ReveiwHealthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
Key inclusion criteria (0 listed)
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 |
|---|---|---|
| Sterile speculum examSterile vaginal speculum exam to include Nitrazine, ferning and pooling observations | Procedure or surgery | women pregnant |
| ROM Plus ExamVaginal swab exam for ROM Plus Test | Procedure or surgery | women pregnant |
| Chart ReveiwPost delivery blinded chart review by expereienced obstetrician | Procedure or surgery | women pregnant |
Primary outcome
Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus
Time frame: 1 week
Patients underwent two assessments to determine positive or negative membrane rupture status: (1) Standard clinical assessment using fluid leaking from the cervical os, or two of the following; pooling, positive nitrazine test, or ferning and (2) A new combination immunoassay ROM Plus containing a combination of monoclonal and polyclonal antibodies to Placental Protein 12 (PP12) and Alpha-fetoprotein (AFP). Then, membrane rupture status was determined by chart review for reference based on a post delivery patient chart review by an experienced physician blinded to ROM Plus results.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundLee SI, Park JS, Norwitz ER et al. Measurement of placental alpha-microglobulin-1 in cervicovaginal discharge to diagnose rupture of membranes, Obstet Gyencol 2007;109:634-40 Cousins, LM, Smok, P. Lovett, SM, Poeltler, DM. AmniSure Placental Alpha Microglobulin-1 Rapid Immunoassay versus Standard Diagnostic Methods for Detection of Rupture of Membranes. American J. of Perinatology. 2005;Vol.20:1-4. Caughey, AB., Robinson, JN., Norwitz, ER. Contemporary Diagnosis and Management of Preterm Premature Rupture of Membranes. Rev. Obstet. Gynecol. 2008;1(1):11-22.
Related trials for Rupture of Amniotic Membranes
Recruiting
Microbiological and Biochemical Profiling of Amniotic Fluid in Women With Short Cervix or Premature Rupture of Membranes
Short Cervix, PROM, Preterm (Pregnancy)
RecruitingPhase 3
TAILORED Therapeutic Regime in Patients With Preterm Premature Rupture Of Membranes to Prolong Pregnancy, Improve Maternal and Neonatal Outcomes, and Reduce Antibiotic Burden
Preterm Premature Rupture of Membranes (PPROM)
RecruitingObservational study
Amniotic Fluid & the Preterm Gut
Chorioamnionitis, Chorioamnionitis Affecting Fetus or Newborn
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rupture of Amniotic Membranes, run by Clinical Innovations, LLC at 1 site in United States.
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 0 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: finished, as of the sponsor's last update on 31 Jul 2012. 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 United States. 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?
Yes. Results are posted in the registry (first posted 31 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01366443, which also lists 1 linked publication.
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 31 Jul 2012.