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OpenTrials
Completed

NCT Number: NCT01366443

Analysis of ROM Plus to Detect Rupture of Membranes

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.

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Key information

Conditions

Rupture of Amniotic Membranes

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Utah Medical Center

Salt Lake City, Utah, 894132, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Exclusion criteria

  • Known placental previa
  • Active vaginal bleeding

Treatment and study plan

Sterile speculum exam

Procedure

Sterile vaginal speculum exam to include Nitrazine, ferning and pooling observations

ROM Plus Exam

Procedure

Vaginal swab exam for ROM Plus Test

Chart Reveiw

Procedure

Post delivery blinded chart review by expereienced obstetrician

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Clinical Innovations, LLC

Industry

Collaborators

  • Midwestern University
  • The Reading Hospital and Medical Center
  • University of Utah

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 6, 2011
Registry last updated
Jul 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.