A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02208011

Enrollment

140

Registered

2014-08-04

Start date

2014-08-31

Completion date

2015-06-30

Last updated

2020-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evidence of Ruptured Membranes in Women Greater Than 15 Weekd

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* active bleeding * placenta previa

Design outcomes

Primary

Measure	Time frame
evidence of ruptured membranes	up to delivery of infant

Countries

United States

Outcome results