A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes

Louisiana State University, Baton Rouge

Status: Completed

Conditions: Evidence of Ruptured Membranes in Women Greater Than 15 Weekd

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02208011

L8608-W13010

Details and patient eligibility

About

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

Enrollment: 140 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• active bleeding
• placenta previa