A Comparison of Rapid Immunoassays for the Detection of R... | NCT02208011

Studies
A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes

NCT02208011

Sponsor

Louisiana State University, Baton Rouge

Status

Completed

Last Update Posted

Sep 2, 2020Actual

Enrollment

140Actual

Phase

Not provided

Conditions

Evidence of Ruptured Membranes in Women Greater Than 15 Weekd

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Aug 1, 2014

First Submission Date that Met QC Criteria

Aug 1, 2014

First Posted Date

Aug 4, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2020

Last Update Posted Date

Sep 2, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Iro Igbinosa, M.D., Louisiana State University, Baton RougePrincipal Investigator

Lead Sponsor

Louisiana State University, Baton RougeOTHER

Collaborators

Name	Class
Woman's Hospital, Louisiana	OTHER
Clinical Innovations, LLC	INDUSTRY
Louisiana State University Health Sciences Center in New Orleans	OTHER

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

140Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
evidence of ruptured membranes		up to delivery of infant

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pregnant woman presenting to Woman's Hospital, LSU Baton Rouge Clinic with ruptured membranes.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Woman's Hospital		Baton Rouge	Louisiana	70817	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28446135	Derived	Igbinosa I, Moore FA 3rd, Johnson C, Block JE. Comparison of rapid immunoassays for rupture of fetal membranes. BMC Pregnancy Childbirth. 2017 Apr 26;17(1):128. doi: 10.1186/s12884-017-1311-y.