NCT01366443

Analysis of ROM Plus to Detect Rupture of Membranes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 288 (actual)
• Sponsor: Clinical Innovations, LLC · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rupture of Amniotic Membranes

Interventions

Type	Name	Description
PROCEDURE	Sterile speculum exam	Sterile vaginal speculum exam to include Nitrazine, ferning and pooling observations
PROCEDURE	ROM Plus Exam	Vaginal swab exam for ROM Plus Test
PROCEDURE	Chart Reveiw	Post delivery blinded chart review by expereienced obstetrician

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2011-06-06
• Last updated: 2012-07-31
• Results posted: 2012-07-31

Locations

1 site across 1 country: United States