Analysis of ROM Plus to Detect Rupture of Membranes

Completed

• Conditions: Rupture of Amniotic Membranes
• Interventions: Procedure: Sterile speculum exam; Procedure: ROM Plus Exam; Procedure: Chart Reveiw

• Registration Number: NCT01366443
• Lead Sponsor: Clinical Innovations, LLC

Brief 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.

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 Timeline

• Study Start: 2010-09
• Study First Submitted: 2011-06-02
• Study First Submitted QC: 2011-06-03
• Study First Posted: 2011-06-06
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2012-04-26
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-30
• Last Update Submitted: 2012-07-30
• Results First Posted: 2012-07-31
• Last Update Posted: 2012-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 288

Inclusion Criteria

Not provided

Exclusion Criteria

• Known placental previa
• Active vaginal bleeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
women pregnant	Sterile speculum exam	Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
women pregnant	ROM Plus Exam	Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
women pregnant	Chart Reveiw	Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.

Primary Outcome Measures

Name	Time	Method
Pregnant Women Positive and Negative for Membrane Rupture Measured Via Clinical Assessment, Chart Review and ROM Plus	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.

Trial Locations

Locations (1)

University of Utah Medical Center; 🇺🇸 Salt Lake City, Utah, United States