A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes
August 31, 2020 updated by: Iro Igbinosa, Louisiana State University, Baton Rouge
Specific objectives include analysis of performance of ROM Plus® in diagnosing ROM, as compared to Amnisure® and the conventional clinical assessment confirmed by a thorough chart review after delivery.
Inclusion Criteria:
- English speaking
- pregnant woman >15 weeks gestation undergoing an exam for ruptured membranes
Exclusion Criteria:
- Known placental previa
- Active vaginal bleeding
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
140
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Louisiana
-
Baton Rouge, Louisiana, United States, 70817
- Woman's Hospital
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Pregnant woman presenting to Woman's Hospital, LSU Baton Rouge Clinic with ruptured membranes.
Description
Inclusion Criteria:
- complaint of ruptured membranes
- IUP > 15 weeks gestation
- English speaking, over the age of 18yrs old
Exclusion Criteria:
- active bleeding
- placenta previa
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
evidence of ruptured membranes
Time Frame: up to delivery of infant
|
up to delivery of infant
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2014
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
August 1, 2014
First Submitted That Met QC Criteria
August 1, 2014
First Posted (Estimate)
August 4, 2014
Study Record Updates
Last Update Posted (Actual)
September 2, 2020
Last Update Submitted That Met QC Criteria
August 31, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- L8608-W13010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.