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A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes

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ClinicalTrials.gov Identifier: NCT02208011
Recruitment Status : Completed
First Posted : August 4, 2014
Last Update Posted : July 21, 2016
Sponsor:
Collaborators:
Woman's Hospital, Louisiana
Clinical Innovations, LLC
Louisiana State University Health Sciences Center in New Orleans
Information provided by (Responsible Party):
Iro Igbinosa, Louisiana State University, Baton Rouge

Brief Summary:

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

Condition or disease
Evidence of Ruptured Membranes in Women >15wks Gestation.

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Study Type : Observational
Actual Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes
Study Start Date : August 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears




Primary Outcome Measures :
  1. evidence of ruptured membranes [ Time Frame: up to delivery of infant ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pregnant woman presenting to Woman's Hospital, LSU Baton Rouge Clinic with ruptured membranes.
Criteria

Inclusion Criteria:

  • complaint of ruptured membranes
  • IUP > 15 weeks gestation
  • English speaking, over the age of 18yrs old

Exclusion Criteria:

  • active bleeding
  • placenta previa

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02208011


Locations
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United States, Louisiana
Woman's Hospital
Baton Rouge, Louisiana, United States, 70817
Sponsors and Collaborators
Louisiana State University, Baton Rouge
Woman's Hospital, Louisiana
Clinical Innovations, LLC
Louisiana State University Health Sciences Center in New Orleans

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Iro Igbinosa, M.D., Louisiana State University, Baton Rouge
ClinicalTrials.gov Identifier: NCT02208011     History of Changes
Other Study ID Numbers: L8608-W13010
First Posted: August 4, 2014    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Rupture
Wounds and Injuries