Vaginal Fluid Wash in Pre-labour Rupture of Membranes (PROM)

Beni-Suef University

Status: Unknown

Conditions: Disorder of Amniotic Cavity and/or Membrane

Treatments: Procedure: Urea and creatinine; Drug: 5ml saline; Procedure: Nitrazine

Study type: Interventional

Funder types: Other

Identifiers

NCT02111148

Beni-Suef 2

Details and patient eligibility

About

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

Full 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.

Enrollment: 105 estimated patients

Sex: Female

Ages: 30 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 3 patient groups

urea and creatinine

Active Comparator group

Description:

urea and creatinine detected in vaginal fluid wash after injecting of 5 ml saline intavaginally

Treatment:

Procedure: Urea and creatinine

Nitrazine

Active Comparator group

Description:

Biochemical description of Nitrazine in the vaginal wash

Treatment:

Procedure: Nitrazine

saline

Active Comparator group

Description:

5ml saline will be injected in vagina of each patient in both groups within 24 hours of membrane rupture.

Treatment:

Drug: 5ml saline