Vaginal Fluid Wash in Pre-labour Rupture of Membranes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Urea and Creatinine Versus Nitrazine Test in Vaginal Fluid Wash in Diagnosed Pre Labour Rupture of Membranes

Conditions
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Disorder of Amniotic Cavity and/or Membrane

Intervention / Treatment
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* Procedure: Urea and creatinine
* Procedure: Nitrazine
* Drug: 5ml saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: urea and creatinine<br>urea and creatinine detected in vaginal fluid wash after injecting of 5 ml saline intavaginally | Procedure: Urea and creatinine<br>* the vagina will be washed with 5ml saline, urea and creatinine will be detected biochemically in the vaginal wash.<br>|
| Active Comparator: Nitrazine<br>Biochemical description of Nitrazine in the vaginal wash | Procedure: Nitrazine<br>* Nitrazine detection in vaginal wash<br>|
| Active Comparator: saline<br>5ml saline will be injected in vagina of each patient in both groups within 24 hours of membrane rupture. | Drug: 5ml saline<br>* the vagina will be washed with 5ml saline and vaginal wash will be collected.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urea and creatinine in vaginal fluid | 5ml saline will be injected vaginally then vaginal fluid will be collected. | Within first 24 hours after rupture of membranes in third trimester | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nitrazine test | 5ml saline is injected vaginally then vaginal fluid is collected | Within first 24 hours after rupture of membranes in third trimester | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rupture of membranes, nitrazine, urea, creatinine