Vaginal Fluid Wash in Pre-labour Rupture of Membranes

Not Applicable

• Conditions: Disorder of Amniotic Cavity and/or Membrane
• Interventions: Procedure: Urea and creatinine; Drug: 5ml saline; Procedure: Nitrazine

• Registration Number: NCT02111148
• Lead Sponsor: Beni-Suef University

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.

Study Timeline

• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-11
• Study Start: 2014-05
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-15
• Last Update Posted: 2021-02-16
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

• Gestational age between 28 and 41 weeks
• Single intrauterine pregnancy
• History of gush of fluid
• Liquor detected on speculum examination

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Exclusion Criteria

• Vaginal bleeding
• Patients in labour
• Contaminated samples

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
urea and creatinine	Urea and creatinine	urea and creatinine detected in vaginal fluid wash after injecting of 5 ml saline intavaginally
saline	5ml saline	5ml saline will be injected in vagina of each patient in both groups within 24 hours of membrane rupture.
Nitrazine	Nitrazine	Biochemical description of Nitrazine in the vaginal wash

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Nitrazine test	Within first 24 hours after rupture of membranes in third trimester	5ml saline is injected vaginally then vaginal fluid is collected

Trial Locations

Locations (1)

Nesreen Abdel Fattah Abdullah Shehata; 🇪🇬 Cairo, Egypt