Woman's Hospital
Baton Rouge, Louisiana, 70817, United States
Completed
NCT Number: NCT02208011
A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes
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
Completed
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Notify MeKey information
Age range
18 year and older
Sex eligibility
Female
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- complaint of ruptured membranes
- IUP > 15 weeks gestation
- English speaking, over the age of 18yrs old
Exclusion criteria
- active bleeding
- placenta previa
Treatment and study plan
Primary outcomes
-
evidence of ruptured membranes
Time frame: up to delivery of infant
Sponsors and collaborators
Lead sponsor
Louisiana State University, Baton Rouge
Other
Collaborators
- Clinical Innovations, LLC
- Louisiana State University Health Sciences Center in New Orleans
- Woman's Hospital, Louisiana
Registry information
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Aug 4, 2014
- Registry last updated
- Sep 2, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.