Vaginal Fluid Wash in Pre-labour Rupture of Membranes

Disorder of Amniotic Cavity and/or Membrane Clinical Trial

— PROM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02111148
• Other study ID #: Beni-Suef 2
• Status: Recruiting
• Phase: N/A
• Start date: May 2014
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Beni-Suef University
• Contact: Nesreen A Shehata, MD
• Phone: 00201024150605
• Email: nesoomar[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Disorder of Amniotic Cavity and/or Membrane
• Fetal Membranes, Premature Rupture
• Rupture

Intervention

Procedure:
• Urea and creatinine
the vagina will be washed with 5ml saline, urea and creatinine will be detected biochemically in the vaginal wash.
• Nitrazine
Nitrazine detection in vaginal wash

Drug:
• 5ml saline
the vagina will be washed with 5ml saline and vaginal wash will be collected.

Locations

Country	Name	City	State
Egypt	Nesreen Abdel Fattah Abdullah Shehata	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Beni-Suef University	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Nitrazine test	5ml saline is injected vaginally then vaginal fluid is collected	Within first 24 hours after rupture of membranes in third trimester