Disorder of Amniotic Cavity and/or Membrane
Conditions
Keywords
rupture of membranes, nitrazine, urea, creatinine
Brief summary
The investigators assess in this study the sensitivity of Urea and Creatinine and that of Nitrazine test in vaginal wash after injecting saline in the vagina of patients with pre-labour rupture of membranes
Detailed description
The aim of this study is to compare the accuracy of measuring the urea and creatinine level versus that of nitrazine test in vaginal wash of pre-labour rupture of membranes patients.Each patient with rupture of membranes will be assessed clinically and then if not in labour , patients will be divided into 2 groups, 5ml saline will be injected in the vagina of each patient in every group then the vaginal wash will be collected in a test tube. Urea and creatinine group, biochemical tests for urea and creatinine in mIU/ml to detect their presence in the wash will be done. In Nitrazine group wash will be assessed by nitrazine paper showing bluish discoloration in rupture membranes. Sensitivity of each test in diagnosed rupture of membranes will be assessed.Which means how many patients in each test show positive results in case of diagnosed case.
Interventions
PROCEDUREUrea and creatinine
the vagina will be washed with 5ml saline, urea and creatinine will be detected biochemically in the vaginal wash.
PROCEDURENitrazine
Nitrazine detection in vaginal wash
DRUG5ml saline
the vagina will be washed with 5ml saline and vaginal wash will be collected.
Sponsors
Cairo University
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Gestational age between 28 and 41 weeks * Single intrauterine pregnancy * History of gush of fluid * Liquor detected on speculum examination
Exclusion criteria
* Vaginal bleeding * Patients in labour * Contaminated samples
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urea and creatinine in vaginal fluid | Within first 24 hours after rupture of membranes in third trimester | 5ml saline will be injected vaginally then vaginal fluid will be collected. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nitrazine test | Within first 24 hours after rupture of membranes in third trimester | 5ml saline is injected vaginally then vaginal fluid is collected |
Countries
Egypt
Contacts
Primary ContactNesreen A Shehata, MD
Outcome results
None listed