Evidence of Ruptured Membranes in Women Greater Than 15 Weekd Clinical Trial
Official title:
A Comparison of Rapid Immunoassays for the Detection of Ruptured Membranes
| NCT number | NCT02208011 |
| Other study ID # | L8608-W13010 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 2014 |
| Est. completion date | June 2015 |
| Verified date | August 2020 |
| Source | Louisiana State University, Baton Rouge |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 140 |
| Est. completion date | June 2015 |
| Est. primary completion date | June 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - complaint of ruptured membranes - IUP > 15 weeks gestation - English speaking, over the age of 18yrs old Exclusion Criteria: - active bleeding - placenta previa |
| Country | Name | City | State |
|---|---|---|---|
| United States | Woman's Hospital | Baton Rouge | Louisiana |
| Lead Sponsor | Collaborator |
|---|---|
| Louisiana State University, Baton Rouge | Clinical Innovations, LLC, Louisiana State University Health Sciences Center in New Orleans, Woman's Hospital, Louisiana |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | evidence of ruptured membranes | up to delivery of infant |