A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes

NCT ID: NCT02208011

Last Updated: 2020-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-06-30

Brief Summary

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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

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Conditions

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Evidence of Ruptured Membranes in Women Greater Than 15 Weekd

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* active bleeding
* placenta previa
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Woman's Hospital, Louisiana

OTHER

Sponsor Role collaborator

Clinical Innovations, LLC

INDUSTRY

Sponsor Role collaborator

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role collaborator

Louisiana State University, Baton Rouge

OTHER

Sponsor Role lead

Responsible Party

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Iro Igbinosa

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Woman's Hospital

Baton Rouge, Louisiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 28446135 (View on PubMed)

Other Identifiers

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L8608-W13010

Identifier Type: -

Identifier Source: org_study_id

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