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

Primary Purpose

Disorder of Amniotic Cavity and/or Membrane

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Urea and creatinine
Nitrazine
5ml saline
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Disorder of Amniotic Cavity and/or Membrane focused on measuring rupture of membranes, nitrazine, urea, creatinine

Eligibility Criteria

30 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Nesreen Abdel Fattah Abdullah ShehataRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

urea and creatinine

Nitrazine

saline

Arm Description

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

Biochemical description of Nitrazine in the vaginal wash

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

Outcomes

Primary Outcome Measures

Urea and creatinine in vaginal fluid
5ml saline will be injected vaginally then vaginal fluid will be collected.

Secondary Outcome Measures

Nitrazine test
5ml saline is injected vaginally then vaginal fluid is collected

Full Information

First Posted
April 2, 2014
Last Updated
February 15, 2021
Sponsor
Beni-Suef University
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT02111148
Brief Title
Vaginal Fluid Wash in Pre-labour Rupture of Membranes
Acronym
PROM
Official Title
Urea and Creatinine Versus Nitrazine Test in Vaginal Fluid Wash in Diagnosed Pre Labour Rupture of Membranes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
Collaborators
Cairo University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disorder of Amniotic Cavity and/or Membrane
Keywords
rupture of membranes, nitrazine, urea, creatinine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
urea and creatinine
Arm Type
Active Comparator
Arm Description
urea and creatinine detected in vaginal fluid wash after injecting of 5 ml saline intavaginally
Arm Title
Nitrazine
Arm Type
Active Comparator
Arm Description
Biochemical description of Nitrazine in the vaginal wash
Arm Title
saline
Arm Type
Active Comparator
Arm Description
5ml saline will be injected in vagina of each patient in both groups within 24 hours of membrane rupture.
Intervention Type
Procedure
Intervention Name(s)
Urea and creatinine
Intervention Description
the vagina will be washed with 5ml saline, urea and creatinine will be detected biochemically in the vaginal wash.
Intervention Type
Procedure
Intervention Name(s)
Nitrazine
Intervention Description
Nitrazine detection in vaginal wash
Intervention Type
Drug
Intervention Name(s)
5ml saline
Intervention Description
the vagina will be washed with 5ml saline and vaginal wash will be collected.
Primary Outcome Measure Information:
Title
Urea and creatinine in vaginal fluid
Description
5ml saline will be injected vaginally then vaginal fluid will be collected.
Time Frame
Within first 24 hours after rupture of membranes in third trimester
Secondary Outcome Measure Information:
Title
Nitrazine test
Description
5ml saline is injected vaginally then vaginal fluid is collected
Time Frame
Within first 24 hours after rupture of membranes in third trimester

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nesreen A Shehata, MD
Phone
00201024150605
Email
nesoomar@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nesreen A Shehata, MD
Organizational Affiliation
Beni-Suef University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nesreen Abdel Fattah Abdullah Shehata
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nesreen A Shehata, MD

12. IPD Sharing Statement

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Vaginal Fluid Wash in Pre-labour Rupture of Membranes

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