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NCT01366443 · ClinicalTrials.gov registry record
Analysis of ROM Plus to Detect Rupture of Membranes
A clinical trial of Rupture of Amniotic Membranes, sponsored by Clinical Innovations.
- Completed
- Registry status
- 288
- Enrollment target
- 1
- Study location
NCT01366443: Completed study of Rupture of Amniotic Membranes, sponsored by Clinical Innovations.
NCT01366443 is a study of Rupture of Amniotic Membranes that has completed, run by Clinical Innovations. The registered enrollment target is 288 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01366443, a study of Rupture of Amniotic Membranes, has completed, sponsored by Clinical Innovations.
- COMPLETED
- Registry status
- 288 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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 pos
Conditions Studied
Interventions
- PROCEDURE Sterile speculum exam
- PROCEDURE ROM Plus Exam
- PROCEDURE Chart Reveiw
Study Locations (1)
Utah
- University of Utah Medical Center - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 288 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-04 |
What the finished NCT01366443 record still lists
NCT01366443 is an observational study that tracks outcomes without assigning an intervention. The registered 288 participants enrollment target is mid-sized for trials with a published cap.
The record links to 1 condition, with Rupture of Amniotic Membranes appearing as the primary indexed condition, and to 3 interventions - of which Sterile speculum exam is the first listed.
NCT01366443 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT01366443 about?
NCT01366443 is a clinical study titled "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.
What is the current status of trial NCT01366443?
This trial is currently completed. The enrollment target is 288 participants. The study started on 2010-09. Estimated completion is 2012-04.
What conditions does trial NCT01366443 study?
This clinical trial studies the following conditions: Rupture of Amniotic Membranes.
What interventions are being tested in trial NCT01366443?
The interventions under investigation include: Sterile speculum exam (PROCEDURE), ROM Plus Exam (PROCEDURE), Chart Reveiw (PROCEDURE).
Who is sponsoring clinical trial NCT01366443?
This trial is sponsored by Clinical Innovations, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01366443 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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