NCT01366443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 6, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
4 months until next milestone

Results Posted

Study results publicly available

July 31, 2012

Completed
Last Updated

July 31, 2012

Status Verified

July 1, 2012

Enrollment Period

1.6 years

First QC Date

June 2, 2011

Results QC Date

April 26, 2012

Last Update Submit

July 30, 2012

Conditions

Rupture of Amniotic Membranes

Keywords

ROM PLUSconventional clinical tests of rupture of membranes (ROM)speculum examvisualization of leakagepooling of amniotic fluid in the posterior fornixnitrazine testingferning

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 week

Study Arms (1)

women pregnant

Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.

Procedure: Sterile speculum examProcedure: ROM Plus ExamProcedure: Chart Reveiw

Interventions

Sterile speculum examPROCEDURE

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

women pregnant
ROM Plus ExamPROCEDURE

Vaginal swab exam for ROM Plus Test

women pregnant
Chart ReveiwPROCEDURE

Post delivery blinded chart review by expereienced obstetrician

women pregnant

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.

You may not qualify if:

  • Known placental previa
  • Active vaginal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah Medical Center

Salt Lake City, Utah, 894132, United States

Location

Related Publications (1)

  • 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.

    BACKGROUND

Results Point of Contact

Title
Dr. Michael Draper, MD University of Utah Medical Center, Dept. of OB/GYN
Organization
University of Utah Medical Center, Dept. of OB/GYN
mike.draper@hsc.utah.edu
801-581-7647

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2011

First Posted

June 6, 2011

Study Start

September 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

July 31, 2012

Results First Posted

July 31, 2012

Record last verified: 2012-07

Locations

US(1)