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

February 15, 2021 updated by: Nesreen Abdel Fattah Abdullah Shehata, Beni-Suef University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Nesreen Abdel Fattah Abdullah Shehata
        • Principal Investigator:
          • Nesreen A Shehata, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Collaborators

Cairo University

Investigators

  • Principal Investigator: Nesreen A Shehata, MD, Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 10, 2014

First Posted (Estimate)

April 11, 2014

Study Record Updates

Last Update Posted (Actual)

February 16, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Beni-Suef 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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